FDA finds 'filth' at compounder repackaging Avastin

September 6, 2012 | By Eric Palmer

The FDA has ordered a compounding pharmacy in Hollywood, FL, to stop repackaging Avastin after some of the syringes of the cancer drug were found to be contaminated with Streptococcus mitis/oralis and other microorganisms and tied to infections. The agency said that given the conditions of the facility and the practices of the employees, the drugs "may have been contaminated with filth."

In a hard-hitting letter hand-delivered during an outbreak investigation, the FDA said repackaging the Avastin, as well as human chorionic gonadotropin (HCG), was well beyond the purview of Infupharma. The FDA warning letter says investigators determined that Infupharma has a contract with another pharmacy to repack Avastin from sterile injectable single-use vials into sterile injectable 1 mL single-use syringes and to repack HCG multiuse vials into single-use syringes for further distribution. But the FDA said the repacking amounted to creating new drugs and that the company was not approved to do that.
Not only that, but the inspectors also found that the employees were untrained and inept and the conditions were unsanitary and that the company did not have separate work areas to "prevent contamination or mix-ups during the course of your aseptic processing."

Read rest of article at: FDA finds 'filth' at compounder repackaging Avastin - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-finds-filth-compounder-repackaging-avastin/2012-09-06#ixzz25iFBBm4m 

FDA Warning Letter to DPT Lakewood, LLC

On August 27, 2012, the FDA issued a warning letter to DPT Lakewood, LLC, located in New Jersey.  The beginning of the letter states:

During our February 15 to March 7, 2012 inspection of your pharmaceutical manufacturing facility located at 1200 Paco Way, Lakewood , NJ, an investigator from the Food and Drug Administration (FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug product, Santyl Ointment, to be adulterated within the meaning of section 501 (a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351 (a)(2)(8)], in that the methods used in, or the facilities or controls used for, the manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.

We have reviewed your firm 's response of March 22, 2012, and note that it lacks sufficient corrective actions.

To read the remainder of this warning letter, click here.

FDA Warning Letters in August

The following warning letters are found here:

August 16, 2012	Farmers Coop Co33	Kansas City District Office	CGMP/Medicated Feed/Adulterated	Not Issued *
August 15, 2012	Dragon Herbs34	Los Angeles District Office	New Drug/Labeling/False & Misleading Claims	Not Issued *
August 15, 2012	Healing Ways35	Los Angeles District Office	New Drug/Labeling/False & Misleading Claims	Not Issued *
August 02, 2012	HSAC Enterprises, Inc. dba Kare-N-Herbs36	New England District Office	Drug/Labeling/False & Misleading Claims	Not Issued *

Enforcement Trends Reveal Record-High Warning Letter Issuances, Common Violations

Regulatory Focus, which requires a subscription found here, contains the following article.

By Alexander Gaffney

The US Food and Drug Administration (FDA) sent more warning letters during 2011 than at any time during the previous 13 years, and FDA official told a San Francisco chapter meeting of the Regulatory Affairs Professionals Society (RAPS). Speaking at a 27 July meeting, Barbara Cassens, director of FDA's San Francisco District office, highlighted recent FDA enforcement trends, including warning letters, injunctions, arrests, convictions, and the most common deficiencies exhibited by medical device and pharmaceutical manufacturers. Read More...

The Center For Drug Evaluation And Research (CDER) is responsible for warning letters used for pharmacy compounding issues.  See the July 2012 Regulatory Procedures manual found here.  The manual provides the following information guidance:

The Compliance Management System (CMS) is now being used for electronic submission of Warning Letter recommendations from district offices. All recommendations by the district offices must use CMS for submitting the proposed Warning Letter, the FDA 483 supporting alleged violations, the EIR, and any written response by the firm. For any questions, or if you need to submit a document as a hardcopy, the CDER contact is: Director, Division of Domestic Drug Quality, 301-796-3255, fax 301-847-8743. Also, see Exhibit 4-1, the agency’s “Procedures for Clearing FDA Warning Letters and Untitled Letters.” All agency components responsible for issuing Warning Letters and Untitled Letters must follow these procedures.

Wisconsin livestock dealer enters into consent decree involving drug residues in cows

FDA NEWS RELEASE

For Immediate Release: July 10, 2012
Media Inquiries: Pat El-Hinnawy, 301-796-4763, patricia.el-hinnawy@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

A Wisconsin livestock company and its owner have entered into a consent decree of permanent injunction resulting from a complaint filed by the U.S. Department of Justice on behalf of the FDA alleging violations of federal food and drug safety requirements.

According to the government’s complaint, Dan Nolan Livestock LLC and its owner, Daniel W. Nolan, of Bonduel, Wisc., did not maintain adequate animal treatment records concerning the drug treatment of food animals. FDA inspectors also found that the company and Nolan used new animal drugs illegally, and did not adequately distinguish between medicated and non-medicated animals for sale for use as human food.

U.S. District Judge William C. Griesbach of the U.S. District Court for the Eastern District of Wisconsin, signed the consent decree on July 9, 2012.

The FDA took the action because it is concerned about the sale of animals for human food that may contain levels of animal drugs and could have the potential for adverse effects on human health.

Among other requirements, the company and Nolan must implement a system that identifies the source of each animal and whether the animal was medicated. The firm also must implement a drug inventory and accountability system and provide purchasers, receivers, and consignees with written statements describing how the animal was medicated, or stating that the animal was not medicated.

If the FDA finds that the defendants are not in compliance with the decree, the agency may require defendants to cease selling and delivering any food animals. Failure to obey the terms of the consent decree could also result in civil or criminal penalties.

The FDA had inspected Dan Nolan Livestock LLC previously after the USDA found violative tissue residues in the defendants’ animals. Such illegal drug residues create potential public health hazards. FDA’s inspections showed that the firm had treated animals in an “extra label” manner without a valid veterinarian-client-patient relationship and lacked adequate animal husbandry practices.

Dan Nolan Livestock had dispensed drugs (gentamicin, tulathromycin and tilmicosin) to animals without a valid prescription from a licensed veterinarian or as prescribed on the label.

For more information:

• Warning Letter¹, December 15, 2004
• Source of letter is here.

FDA's shutting down of faulty drug manufacturing facilities 'over-aggressive and excessive,' says Congress

(NaturalNews) Several members of Congress are up in arms over the U.S. Food and Drug Administration (FDA)'s recent crackdown on faulty drug manufacturing facilities across the country. According to the Washington Examiner and several other news outlets, House Oversight and Government Reform Committee (HOGRC) Chairman Darrell Issa (R-Cal.) has issued a public statement in protest of the FDA's regulatory actions, dubbing them "over-aggressive and excessive," and responsible for causing widespread shortages of "life-saving" drugs.

Dozens of drugs have had to be recalled just within the past year due to contamination, production, labeling, and dosage problems, which is why the FDA sent out 1,720 warning letters to drug companies -- the agency only sent out 474 warning letters in 2009 -- notifying them that changes needed to be made. But now Congress has turned the issue into a partisan one, and is actually accusing the FDA of doing too much in trying to protect the public from unsafe drugs.

Rep. Issa flip-flops on FDA enforcement actions
As many NaturalNews readers will remember, McNeil Consumer Healthcare, a division of Johnson & Johnson (J&J), voluntarily shut down its Fort Washington, Penn., facility back in 2010 after a series of drug recalls that included several million containers of various children's medicines. (http://www.naturalnews.com/030504_Johnson_&_recalls.html) It turned out that the McNeil manufacturing plant producing these medicines was infested with bacteria and filth. (http://consumerist.com)

At that time, Rep. Issa and several others issued a joint statement expressing concern about the filthy conditions at the McNeil plant, and actually indicted the FDA for allegedly failing to conduct proper inspections and recall procedures that Rep. Issa and others implied would have kept the public safe from the tainted products. (http://www.ipqpubs.com) Now, however, more than two years after his previous statements, Rep. Issa is singing a different tune, claiming that the FDA is doing too much to protect the public.

According to Rep. Issa, drug companies are having to slow or even stop production of certain "life-saving" drugs in order to come into compliance with FDA standards. So putting the lives of millions of patients at risk from exposure to tainted drugs is apparently not that big of a priority anymore since the FDA's regulatory actions are now cutting into Big Pharma's profit margins -- or as Rep. Issa and his cohorts have put it, "failing to ensure the availability of quality products."

So when the FDA steps in to stop drug companies from dispensing contaminated drugs, the agency is needlessly obstructing the nation's supply chain of critical drugs, in Rep. Issa's opinion. But when the FDA pursues supplement manufacturers, threatens walnut and cherry growers, and shuts down family farms (http://www.naturalnews.com/033280_FDA_raids_timeline.html" target="_blank">http://www.naturalnews.com/033280_FDA_raids_timeline.html), it is apparently just business as usual in the corrupt world of regulatory politics.

Rep. Issa was nowhere to be found when the FDA needlessly destroyed the entire business of Pennsylvania Amish farmer Dan Allgyer, obstructing access to that area's supply chain of raw milk. (http://www.naturalnews.com/035000_Amish_farmers_raw_milk_feds.html) He was also nowhere to be found when the FDA participated in a SWAT-style raid on Rawesome Foods near Los Angeles, Cal., which interfered with that local area's supply chain of organic, natural, and untainted foods. (http://www.naturalnews.com/033220_Rawesome_Foods_armed_raids.html)

For once, the FDA is actually doing a decent job of pursuing the dirty players in the drug industry, and Rep. Issa and others in Congress are complaining that these actions are inappropriate. It just goes to show how deeply corrupted the American political system has become.

Sources for this article include:

http://campaign2012.washingtonexaminer.com

http://in.reuters.com

http://www.forbes.com

Learn more: http://www.naturalnews.com/036390_drug_factories_FDA_violations.html#ixzz1ztnNOXfE

This article can be found here.

U.S. Marshals seized misbranded drugs in Maine

FDA NEWS RELEASE

 

For Immediate Release: June 6, 2012

Media Inquiries: Pat El-Hinnaway, 301-796-4763, patricia.el-hinnawy@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

U.S. Marshals seized misbranded drugs in MainePortland company promoted their products for disease diagnosis, treatment 

On May 31, 2012, at the request of the U.S. Food and Drug Administration, U.S. Marshals seized drug products from Global Biotechnologies, Inc., of Portland, Maine, pursuant to a warrant issued by the U.S. District Court for the District of Maine.

 

According to the complaint, the company has made claims on its website, in promotional materials, and on the products’ labels that its products can diagnose, cure, mitigate, treat or prevent human diseases. The company’s products, including Glucanol, Healthy Trac, Immunol, and Lactopril, meet the FDA definition of drugs because Global Biotechnologies promoted them to treat diseases. However, the company failed to provide adequate directions for use for its drug products, causing those products to be misbranded drugs in violation of the Federal Food, Drug and Cosmetic Act.

 

“The public relies on the FDA to keep companies from claiming that their products improve medical conditions or diseases,” said Armando Zamora, acting director, office of enforcement, in the Office of Regulatory Affairs. “Using these products in the mistaken belief that they will cure a disease – especially when they cannot do so – represents a danger to the public’s health.”

 

Earlier, the FDA sent a warning letter to Global Biotechnologies advising the company that making treatment claims on its labels, promotional materials and websites caused the products to be unapproved new drugs and misbranded drugs in violation of the Federal, Food, Drug and Cosmetic Act. At that time, the company committed to removing drug claims cited in the warning letter from its labeling. However, during a recent inspection, the FDA found that the company had continued to make illegal claims that cause their products to be misbranded drugs.

 

No illnesses have been associated to date with Global Biotechnologies’ products. Illnesses or adverse events related to use of these products should be reported to the FDA at caers@fda.hhs.gov or by calling 240-402-2405.

 

For more information:

• FDA Warning Letter, Feb. 8, 2006

 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation and for regulating tobacco products.

FDA's Regulatory Procedures Manual Effective May 2012 Regarding Advisory Actions Such as Warning Letters

Regulatory Procedures Manual – May 2012 Chapter 4 Advisory Actions
____________________________________________________________________
4-1
Chapter 4
ADVISORY ACTIONS
This chapter defines and establishes uniform guidance and procedures for
Warning Letters and Untitled Letters.
This chapter includes the following sections:
Section Topic  _____Page
4-1 WARNING LETTERS ......................................................................................... 4-2
4-1-1 Warning Letter Procedures................................................................................. 4-2
4-1-2 Warning Letters To Government Agencies......................................................... 4-3
4-1-3 Issuing Warning Letters - Factors to Consider.................................................... 4-4
4-1-4 Center Concurrence And Letters Issued By Centers.......................................... 4-6
4-1-5 Letters For Illegal Promotional Activities........................................................... 4-11
4-1-6 Multiple Center Review..................................................................................... 4-12
4-1-7 Time Frames..................................................................................................... 4-12
4-1-8 Warning Letter Follow-Up ................................................................................. 4-13
4-1-9 Firm Profile Updates in FACTS......................................................................... 4-16
4-1-10 Warning Letter Format...................................................................................... 4-16
4-1-11 Warning Letter Distribution ............................................................................... 4-20
4-1-12 Warning and Untitled Letters Addressed to Importers, Custom Brokers,
and Foreign Firms............................................................................................................ 4-21
4-1-13 Freedom of Information (FOI)........................................................................... 4-22
4-1-14 Center For Biologics Evaluation And Research (CBER)................................... 4-23
4-1-15 Center For Drug Evaluation And Research (CDER)......................................... 4-25
4-1-16 Center For Devices And Radiological Health (CDRH) ...................................... 4-29
4-1-17 Center For Food Safety And Applied Nutrition (CFSAN) and Center for
Veterinary Medicine (CVM).............................................................................................. 4-31
4-1-18 Center for Tobacco Products (CTP) ................................................................. 4-31
4-1-19 Tracking................................................................................................................ 4-32
4-2 UNTITLED LETTERS....................................................................................... 4-33
4-2-1 Policy ................................................................................................................ 4-33
4-2-2 Center Concurrence and Letters Issued By Centers ........................................ 4-33
4-2-3 Tracking ............................................................................................................ 4-34
4-3 USE OF STATE EVIDENCE FOR FDA WARNING LETTERS AND
UNTITLED LETTERS.......................................................................................................... 4-34
4-4 EXHIBITS ......................................................................................................... 4-36Regulatory Procedures Manual – May 2012 Chapter 4 Advisory Actions
____________________________________________________________________
4-2
4-1 WARNING LETTERS
4-1-1 Warning Letter Procedures
When it is consistent with the public protection responsibilities of the agency and
depending on the nature of the violation, it is the Food and Drug Administration’s

FDA Indicates It Will Be Tightening Up Oversight of Overseas Manufacturers

The FDA has issued warning letters to eight overseas companies for importing drugs into the U.S. without registering their production facilities.  The United States Government Accountability Office (GAO) previously criticized the FDA for not properly overseeing overseas facilities.  The warning letters went to the following companies:

China-based Zhejiang Xianju Chemical Pharmaceutical Factory-- to read warning letter click here;
Chinese Peptide Company-- to read warning letter click here; to read close out letter click here;
India-based Sal Pharma-- to read warning letter click here; to read close out letter click here;
India-based Pan Drugs--to read warning letter click here;
Colombia-based CI Famacapsulas--to read warning letter click here;
Hong Kong-based Peking Medicine Manufactory--to read warning letter click here;
South Korea-based Korea Pharma Company--to read warning letter click here;
France-based Orlane--to read warning letter click here; to read close out letter click here;

The FDA had already warned each company of the need to register but the companies had failed to do so. The warning letters state:

Our records indicate that you have not registered  your establishment within 2011 or 2012, but have continued to manufacture, prepare, propagate, compound, or process drugs that were being imported or offered for import into the US. 

The warning letter also indicates that customs may refuse imports of these companies drugs until the companies register their facilities online.

2012 FDA Warning Letters

The FDA has issued the following warning letters in 2012:  The link for the warning letters can be found here.

 

Office of Compliance/Immediate Office

Company/Individual	Product/Issue	Issue Date
C.I. Farmacapsulas S.A. (WARNING LETTER)	failure to register	5/15/12
Sal Pharma (WARNING LETTER)	failure to register	4/24/12
Peking Medicine Manufactory (WARNING LETTER)	failure to register	4/5/12
Korea Pharma Company Ltd (WARNING LETTER)	failure to register	3/26/12
Orlane S.A. (WARNING LETTER)	failure to register	3/15/12
Pan Drugs Limited (WARNING LETTER)	failure to register	2/28/12
Chinese Peptide Company (WARNING LETTER)	failure to register	2/28/12
Zhejiang Xianju Chemical Pharmaceutical Factory (WARNING LETTER)	failure to register	1/25/12

 

 

Office of Drug Security, Integrity and Recalls 

Company/Individual	Product/Issue	Issue Date

 

Office of Unapproved Drugs and Labeling Compliance

Company/Individual	Product/Issue	Issue Date

Office of Manufacturing and Product Quality

Company/Individual	Product/Issue	Issue Date
B.M.P. Pharma Trading AG (WARNING LETTER)	manufacture of APIs	5/4/12
Selder S.A. de C.V. (WARNING LETTER)	regulations for finished pharmaceuticals	4/27/12
Tedec-Meiji Farma, S.A. (WARNING LETTER)	regulations for finished pharmaceuticals	4/24/12
UNAM, Facultad De Estudios Superiores Cuautitlan (WARNING LETTER)	manufacture of APIs	3/24/12
Farma Quimia S.A. de C.V. (WARNING LETTER)	manufacture of APIs	3/9/12
Pax-All Manufacturing, Inc. (WARNING LETTER)	significant violations of Current Good Manufacturing Practice (CGMP)	3/9/12
Laboratorios Jaloma S.A. de C.V. (WARNING LETTER)	significant violations of Current Good Manufacturing Practice (CGMP)	3/9/12
Nobilus Ent (WARNING LETTER)	manufacture of APIs	3/7/12
Wintac Limited (WARNING LETTER)	regulations for finished pharmaceuticals	2/23/12
Gulf Pharmaceutical Industries (WARNING LETTER)	significant violations of Current Good Manufacturing Practice (CGMP)	2/23/12

  

Office of Scientific Investigations

Company/Individual	Product/Issue	Issue Date
Merck Sharp and Dohme Corp. (WARNING LETTER)	Postmarket Requirements (PMRs)	2/17/12

FDA Warning Letters for International APIs in 2011

The following blog post can be found here.

FDA Warning Letters for International APIs in 2011

January 8, 2012

FDA issued at least ten Warning Letters to international manufacturers of active pharmaceutical ingredients in FY-2011. Manufacturers in both China and India, the world’s largest exporters of APIs, received three Warning Letters each from FDA. Manufacturers in Spain, the UK, Canada, and Japan each received one Warning Letter from FDA. These metrics show both the domination of China and India in the API market as well as the continued dependence on international manufacturers for APIs destined for the U.S. market.
Deficiency Categories:
The violation that dominated the charges cited by FDA in FY-2011 related to quality control, cited in four Warning Letters, two to China and one each to Canada and Japan.
Another violation that is sure to cause concern with FDA is the failure to prevent cross-contamination. When I attended FDA API inspection training in 2000 cross-contamination, particularly with anti-biotics, was a major concern. It continues to be with API manufacturers in both India and China being cited for the “Failure to have appropriate procedures in place to prevent cross-contamination.”
Out of specification (OOS) laboratory results are always a concern of FDA and landed on Warning Letters to manufacturers in India and Spain. Other citations include:
= Water purification for APIs used in parenterals
= Failure to establish a stability program to monitor APIs
= Failure to perform at least one identity test of each batch of incoming material
= Validation of analytical methods used to test APIs
There are no big surprises here but it shows that regular surveillance of API vendors is an absolute necessity for the manufacture of quality drug products. What is of interest is that GxP Perspectives couldn’t find any domestic Warning Letters for APIs. That doesn’t mean they don’t exist, only that they couldn’t be easily located. Unfortunately, FDA lists API Warning Letters in any number of classifications for GMPs for finished pharmaceuticals. However, they don’t seem to list them for APIs. With all the razzle-dazzle taking place on FDA’s website, you would think they could come up with a consistent way to list API Warning Letters. Who knows, maybe next year.
by Carl Anderson, GxP Perspectives
Research by Francesca Carreras-Perez, GxP Perspectives
====

Merck Receives Unusual, Holistic Warning Letter from FDA

Merck Receives Unusual, Holistic Warning Letter from FDA

February 16th, 2012 // 2:34 pm @ jmpickett

Source: http://www.pharmalot.com/
In what appears to be a calculated review of a supply chain, the FDA last summer inspected three Merck KGgA manufacturing plants in Europe – one that makes active pharmaceutical ingredients, another that makes finished prescription drugs and a third that is responsible for testing meds for the US market – and all three failed the inspections.

The details of the assorted manufacturing failures – and there are many details because there were many failures – can be found in a December 15, 2011, warning letter that the FDA has just posted to its web site. They range from failing to establish procedures for preventing microbial contamination to not thoroughly investigating the failure of a batch of product to meet specifications.

What is noteworthy is that the FDA made a point of simultaneously inspecting different facilities that fulfill different but highly specific steps along the Merck supply chain. As opposed to merely visiting different plants that make different medications, the agency, in this instance, took a strategic view toward Merck operations that send drugs to the US market. Call it the holistic view.

The move comes, of course, as the FDA is under increasing pressure to bolster its oversight of manufacturing operations in the US and elsewhere in the wake of the Heparin scandal (see this). The White House, for instance, included $10 million in the proposed FDA budget for hiring 19 inspectors to focus just on China, with 16 work there on food and drug safety and standards.

And the FDA was rather clear about the take-away message. The “FDA expects Merck KGaA to undertake a comprehensive and global assessment of your manufacturing operations in all your facilities to ensure global, adequate, and timely resolution of the issues, including making needed improvements to your quality system,” the agency wrote to Merck chairman Karl-Ludwig Kley

FDA Warning Letter to Sichuan Pharmaceutical Co., Ltd./ API from China

Warning Letter

VIA UPS MAIL

WL: 320-11-019

September 09, 2011

Mr. Wang Gouping
General Manager
Sichuan Pharmaceutical Co., Ltd.
No. 189 Hualong Road
Pengzhou, Sichuan, China 611930

Dear Mr. Gouping:

During our June 23 to 29, 2010 inspection of your active pharmaceutical ingredient (API) manufacturing facility, Sichuan Pharmaceutical Co., Ltd. located at No. 189 Hualong Road, Pengzhou, Sichuan, China, an investigator from the Food and Drug Administration (FDA) identified significant deviations from Current Good Manufacturing Practice (CGMP) for the manufacture of APIs. These deviations cause your API(s) to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.

We have reviewed your firm’s response of August 05, 2010 and December 13, 2010, and note that it lacks sufficient corrective actions.
Specific deviations observed during the inspection include, but are not limited, to the following:

1. Failure to have appropriate procedures in place to prevent cross-contamination.

From September 2008 to July 2009 your firm manufactured (b)(4) API in workshop (b)(4), which is adjacent to workshops (b)(4) and (b)(4) where you manufactured (b)(4) API and (b)(4) injection, respectively. However, you failed to have adequate controls and monitoring program to prevent cross-contamination between these adjacent workshops.

In addition, your firm manufactures a (b)(4) API ((b)(4) (API) in a facility that was previously used to manufacture (b)(4) without conducting adequate decontamination, renovation, and activation of the facility. Your firm has failed to conduct adequate assessment of the cross-contamination risks.

Please note that analytical testing of a product for possible contamination with (b)(4) is not sufficient to ensure adequate conditions for (b)(4) manufacture. In your response to this letter include your plans for decontamination, renovation, and reactivation (if appropriate) of your facility including the decontamination agent, decontamination plans, analytical methodology for environmental and product testing, and the data obtained to support the effectiveness of the decontamination plan.

The deviations detailed in this letter are not intended to be an all-inclusive statement of deviations that exist at your facility. You are responsible for investigating and determining the causes of the deviations identified above and for preventing their recurrence and the occurrence of other deviations. If you wish to continue to ship APIs to the United States, it is the responsibility of your firm to ensure compliance with all U.S. standards for CGMP and all applicable U.S. laws and regulations.

Additionally, your firm is neither registered nor has it listed every API in commercial distribution in the United States with FDA, as required by 21 C.F.R. § 207.40 and section 510(i) of the Act [21 U.S.C. § 360(i)]. Information on how to register and list is available at the following internet website:http://www.fda.gov/cder/drls/registration_listing.htm. You must complete the required registration and listing and provide evidence that you have fulfilled these requirements in your response to this letter.

Until all corrections have been completed and FDA has confirmed corrections of the deviations and your firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as an API manufacturer. In addition, failure to correct these deviations may result in FDA refusing admission of articles manufactured at Sichuan Pharmaceutical Co., Ltd. located at No. 189 Hualong Road, Pengzhou, Sichuan, China into the United States. The articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act [21 U.S.C. § 381(a)(3)] in that the methods and controls used in their manufacture do not appear to conform to Current Good Manufacturing Practice within the meaning of section 501(a)(2)(B) of the Act [21 U.S.C. § 351(a)(2)(B)].

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct deviations. Include an explanation of each step being taken to prevent the recurrence of deviations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction.

Additionally, your response should state if you no longer manufacture or distribute (b)(4) API and provide the date(s) and reason(s) you ceased production. Please identify your response with FEI # 3002808073.

If you have questions or concerns regarding this letter, contact Milva E. Meléndez, Compliance Officer, at the below address and telephone number.

U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Office of Manufacturing and Product Quality
Division of International Drug Quality
White Oak, Building 51
10903 New Hampshire Ave
Silver Spring, MD 20993
Tel: (301) 796-0662
Fax: (301) 847-8741

Sincerely,

/Steven Lynn/
Steven Lynn
Director
Office of Manufacturing and Product Quality
Office of Compliance

List of FDA Warning Letters to Compounding Pharmacies

Although the following website located here has not been updated since 2010, it contains a list of the FDA Warning Letters to Compounding Pharmacies and Suppliers.  The website contains the following information:

FDA Warning Letters to 
Compounding Pharmacies and Suppliers

The U.S. Food and Drug Administration (FDA) regulates the labeling and sale of foods, drugs, cosmetics, biologicals, and medical devices in interstate commerce. A warning letter is a serious notice to that a marketer appears to be violating federal law and may be subject to enforcement action if the apparent violation continues. Enforcement actions include seizure of goods, injunctions, criminal prosecutions, fines, and imprisonment. Most sellers do what FDA requests. This page indexes warning letters sent to compounding pharmacies and supllier that have prepared or distributed prescription drugs or other drug products that lack FDA approval.

• American Hormones, Inc. / Govind Gil (1/10/08): Testosterone lipoderm gel, thyroid (T4/T3) capsules, pregnenolone capsules, DHEA (dehydroepiandrosterone) capsules, and human growth hormone products
• Axium Healthcare Pharmacy / James Peter Sumerville (6/7/04): domperidone, ribavirin
• Bellevue Pharmacy Solutions / Paul Huesemen (1/14/08): Compounded hyaluronidase, progesterone, diphenhydramine, dimenhydrinate, folic acid, pyridoxine, thiamine, and EDTA (edetate disodium)
• Cape Drugs / Tom Wilson (7/11/05): domperidone
• Civic Center Pharmacy / Ari S. Schafer (12/16/08): Estriol (Bioidentical hormones)
• College Pharmacy / Thomas Bader (4/7/99): riboflavin injection
• Drugs Are Us / Hopewell Pharmacy / Gene Ragazzo and James Palmieri (6/7/04): adenosine monophosphate, human growth hormone, polidocanol, domperidone
• Farmacia La Salud / Raul Sanchez (3/26/08): Inhalant solutions
• Hal’s Compounding Pharmacy / Harold Keller (12/4/06): lidocaine, prilocaine, benzocaine, tetracaine, DMSO, progesterone, tretinoin
• Hawkins, Inc / John R. Hawkins (9/8/06): acyclovir, amitriptyline, cyclosporin A, dexamethasone, gentamicin
• Murray Avenue Apothecary / Susan Merenstein (1/7/08): "bioidentical" hormones
• New England Compounding Center / Barry J. Cadden (12/4/06): trypan blue ophthalmic solution, aminolevulinic acid, benzocaine, lidocaine, tetracaine, p-aminobenzoic acid (PABA)
• Newman, Inc. / Medi-Stat / Daniel A. Newman (3/26/08): Keto-Stat, Neuro-Stat, Neuro-Dystonia, Shingles TDO, and Gout TDO
• Pacifica Pharmacy / Jeffrey Barris (1/7/08): "bioidentical" hormones
• Palace Pharmacy / Joel Maertens (3/23/05): domperidone
• Panorama Compounding Pharmacy / Earl Broidy (1/7/08 "bioidentical" hormones
• Peoples Pharmacy / Bill Swail (6/7/04): betamethasone, cisapride, domperidone
• Pharmacy Compounding Specialties / James Porter (1/7/08): "bioidentical" hormones
• Professional Compounding Centers of America / David L. Sparks (7/27/01): phenacetin, dipyrone, dihydrostreptomycin sulfate, adenosine phosphate, chloroform
• Reed's Compounding Pharmacy / Thomas Reed, Dana Reed-King (1/7/08) : "bioidentical" hormones
• Saint John's Medical Plaza Pharmacy / Nancy Mavadat (1/7/08: "bioidentical" hormones
• Sargent's Drug Store / Glenn S. Balas (7/12/91): Sargenti root canal powder
• Steven's Pharmacy / Charles T. Bonner (11/12/08): topical anesthetic products
• Tiberius, Inc. / James G. Castillo (12/4/06): fidocaine, prilocaine, phenylephrine, lidocaine, polidocanol, DNCB
• Village Compounding Pharmacy / Phil Pylant (1/7/08): "bioidentical" hormones

This page was revised on July 19, 2010.

FDA Website with Index to Major Warning Letters

FDA's website http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/

PharmacyCompounding/default.htm contains an index with links to major compliance 

actions and major warning letters issued to compounder through March 2011.  Anyone

considering doing business with a compounder should check to see if warning letter or 

action has been taken by the FDA or the state pharmacy boards.    The index for the FDA

website  appears as follows:

Pharmacy Compounding

Pharmacy Compounding News

• FDA Statement on Makena¹ (3/30/2011)
• News for Pharmacy Compounders in Regards to Possible Melamine Contamination of Pharmaceutical Components² (9/28/2009)
• Medical Center Pharmacy v. Mukasey³ (8/14/2008)

Significant Compliance Actions

• 2010
  • FDA News: FDA Issues Warning Letters for Drugs Promoted in Fat Elimination Procedure⁴ (4/7/2010)
    • Pure Med Spa⁵
    • All about you medispa⁶
    • Idinhealth⁷
    • Spa 35⁸
    • Monarch medispa⁹
    • Medical Cosmetic¹⁰
    • Zipmed and Mesoone¹¹
  • Warning Letters
    • VanderVeer Center, 11/18/10, Center for Drug Evaluation and Research (CDER)¹²
    • Med Prep Consulting, 7/9/10, New Jersey District Office¹³
    • J & F International Inc., dba Alexandria Medical Arts Pharmacy & Compounding Laboratory, 4/9/2010, Baltimore District Office¹⁴
      
      
• 2009
  • Warning Letters
    • Hopewell Pharmacy and Compounding Center, 9/28/2009, Center for Drug Evaluation and Research (CDER)¹⁵
• 2008
  • FDA News: FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs¹⁶ (1/9/2008)
    • Panorama Compounding Pharmacy¹⁷
    • Saint John's Medical Plaza Pharmacy¹⁸
    • Murray Avenue Apothecary¹⁹
    • Village Compounding Pharmacy²⁰
    • Pharmacy Compounding Specialties²¹
    • Reed's Compounding Pharmacy²²
    • Pacifica Pharmacy²³
  • Warning Letters
    • Civic Center Pharmacy, 12/16/2008, Los Angeles District Office ²⁴
    • Steven's Pharmacy, 11/12/2008, Los Angeles District Office²⁵
    • Aerosol Science Laboratories Inc., 10/29/2008, Center for Drug Evaluation and Research (CDER)²⁶
    • Newman Inc., (dba Medi-Stat), 6/24/2008, New Orleans District Office²⁷
    • Farmacia La Salud Inc., 3/26/2008 San Juan District Office²⁸
    • Bellevue Pharmacy Solutions, 1/14/2008, Kansas City District Office²⁹
    • American Hormones, Inc., 1/10/2008, New York District Office ³⁰
• 2007
  • Warning Letters
    • Med-South Pharmacy Inc., 9/28/2007, New Orleans District Office³¹
    • PharMEDium Services, LLC, 4/13/2007, Dallas District Office³²
    • ComputeRx/Broncho-Dose, Ltd. 3/21/2007, New England District Office³³
    • Kalchem International, Inc., 1/8/2007, Dallas District Office ³⁴
• 2006
  • FDA News: FDA Warns Five Firms To Stop Compounding Topical Anesthetic Creams³⁵ (12/5/2006)
    • Triangle Compounding Pharmacy³⁶
    • University Pharmacy³⁷
    • Custom Scripts Pharmacy³⁸
    • Hal’s Compounding Pharmacy, Inc.³⁹
    • New England Compounding Center⁴⁰
  • FDA News: FDA Warns Three Pharmacies To Stop Mass-Producing Unapproved Inhalation Drugs⁴¹ (8/10/2006)
    • Rotech Healthcare, Inc.⁴²
    • CCS Medical⁴³
  • Warning Letters
    • Spoonamore Drug Co., Inc., 12/1/2006, Cincinnati District Office ⁴⁴
    • Health Dimensions, Inc., 11/27/2006, Detroit District Office ⁴⁵
    • Pharmacy Creations, 10/31/2006, New Jersey District Office⁴⁶
    • Wedgewood Village Pharmacy, 10/31/2006, New Jersey District Office⁴⁷
    • B. Braun Medical Inc., 3/15/2006, Philadelphia District Office⁴⁸
    • Southern Meds Joint Venture, LLC, 2/15/2006, New Orleans District Office⁴⁹
• 2004
  • FDA News: FDA Warns Against Women Using Unapproved Drug, Domperidone, to Increase Milk Production⁵⁰
  • Warning Letters
    • Axium Healthcare Pharmacy⁵¹
    • Drugs Are Us (dba Hopewell Pharmacy)⁵²
    • Peoples Pharmacy, Inc.⁵³
    • Spectrum Chemicals and Laboratory Products⁵⁴

Pharmacy Compounding Advisory Committee Materials⁵⁵

Compounding Surveys

• Report: 2006 Limited FDA Survey of Compounded Drug Products⁵⁶
• Report: Limited FDA Survey of Compounded Drug Products⁵⁷ (2/13/2003)