Monday, September 4, 2017

List of Outsourcing Facilities Registered with the FDA as of 9/4/2017

acility NameInitial Date of Registration as an Outsourcing Facility1Date of Most Recent Registration as an Outsourcing Facility1End Date of Last FDA Inspection Related to Compounding2Was a Form FDA-483 issued?3Other Action, if Any, Based on Last Inspection4,5Intends to Compounds Sterile Drugs From Bulk Drug Substances6
Advanced Pharma, Inc. dba Avella of Houston, Houston, TX12/21/201612/21/20167/22/2016YesOpenNo
AnazaoHealth Corporation, Las Vegas, NV9/23/201410/18/20163/24/2017YesOpen7Yes
ASP CARES, San Antonio, TX2/14/20172/14/20173/2/2017YesOpenYes
Athenex Pharma Solutions, LLC, Clarence, NY4/10/20174/10/2017Not yet inspectedN/AN/ANo
Atlas Pharmaceuticals, Phoenix, AZ11/8/201611/8/2016Not yet inspectedN/A N/A Yes 
Auro Pharmacies, Inc, DBA Central Drugs, 511 S. Harbor Blvd, Bldg F, La Habra, CA9/1/201610/19/20166/29/2017YesOpen7Yes
Avella of Deer Valley, Inc. #38, Phoenix, AZ6/21/201610/8/20164/24/2017NoOpenN/A
Avella Specialty Pharmacy, Phoenix, AZ2/24/201410/13/20167/31/2015YesUntitled Letter - 2/3/20177No
Banner Health, Chandler, AZ12/26/201311/23/20163/20/2015YesWarning Letter - 5/5/16No
Bella Pharmaceuticals, Inc., Chicago, IL2/23/20172/23/2017Not yet inspectedN/AN/AYes
Bioserv Corporation, San Diego, CA2/23/20161/25/2017Not yet inspectedN/AN/AYes
Brookfield Medical/Surgical Supply, Inc., Brookfield, CT1/12/201512/21/20164/9/2015YesWarning Letter - 7/5/2016Yes
BSO LLC, Lakewood, CO11/24/201511/7/20169/2/2016YesOpenYes
California Pharmacy and Compounding Center, Newport Beach, CA4/30/201411/18/20164/21/2017YesOpen7Yes
Cantrell Drug Company, Little Rock, AR12/16/201310/12/20166/29/2017YesCeased sterile operations and recalled sterile productsYes
Central Admixture Pharmacy Services, Inc., Allentown, PA2/28/201411/3/20169/19/2016YesOpen7Yes
Central Admixture Pharmacy Services, Inc., San Diego, CA
6/4/201411/3/20168/8/2014YesWarning Letter - 8/18/16No
Coastal Meds LLC, Biloxi, MS12/23/201412/6/20169/23/2015YesWarning Letter - 6/22/2016Yes
Complete Pharmacy and Medical Solutions, LLC, Miami Lakes, FL6/6/20141/4/20172/23/2017YesOpen7Yes
Delta Pharma, Inc., Ripley, MS8/6/201410/26/20162/23/2017YesOpen7Yes
Denver Solutions, LLC dba Leiters Health, Englewood, CO3/24/20173/24/2017Not yet inspectedN/AN/AYes
Eagle Pharmacy, Inc., Birmingham, AL6/16/201510/20/20168/21/2015YesWarning Letter - 10/13/2016Yes
Edge Pharmacy Services, LLC, Colchester, VT1/21/201411/4/20161/20/2017YesOpen7Yes
Empower Pharmacy, Houston, TX7/16/201610/13/2016Not yet inspectedN/AOpenYes
Exela Pharma Sciences, LLC, Lenoir, NC 6/6/2014 6/23/2017 11/21/2014 Yes Untitled Letter - 4/28/2016 Yes 
F.H. Investments, Inc., DBA Asteria Health, Birmingham, AL5/18/20175/18/2017Not yet inspectedN/AN/AYes
Fagron Compounding Services d/b/a Fagron Sterile Services, Wichita, KS10/2/201510/27/20169/21/2016YesOpenYes
Fresenius Kabi Compounding, LLC, Canton, MA4/21/20174/21/2017Not yet inspectedN/AN/ANo
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical, Los Angeles, CA1/6/20171/6/20173/23/2017YesOpenYes
Hybrid Pharma, LLC, Deerfield Beach, FL1/14/201512/20/20167/28/2016YesOpenYes
Imprimis NJOF, LLC, Ledgewood, NJ11/12/201611/12/20167/10/2017YesOpenYes
Infusion Options Inc., Brooklyn, NY1/24/201412/8/20166/1/2017YesOpen7No
Isomeric Pharmacy Solutions, LLC, Salt Lake City, UT7/14/20151/25/20173/24/2017YesCeased sterile operations and recalled sterile products7Yes
JCB Laboratories, North Wichita, KS
1/21/201410/27/201612/3/2015YesOpen7Yes
KRS Global Biotechnology, Inc., Boca Raton, FL12/15/20131/3/20178/31/2016YesOpen7Yes
LeeSar, Inc., Fort Myers, FL4/30/201411/11/20167/7/2017YesOpenNo
Leiter's Compounding, 17 Great Oaks Blvd., San Jose, CA1/31/201410/28/20166/15/2017YesOpen7Yes
Medcraft LLC, Mounds, OK2/23/20172/23/2017Not yet inspectedN/AN/AYes
Medi-Fare Drug, Blacksburg, SC12/17/201311/9/20164/5/2017NoOpen7Yes
Nephron Sterile Compounding Center, LLC (NSCC), West Columbia, SC7/15/201410/21/20164/21/2017YesOpenYes
New England Life Care, Inc. dba: Advanced Compounding Solutions, Woburn, MA3/2/20173/2/2017Not yet inspectedN/AN/ANo
Nubratori, Inc., Torrance, CA2/24/20172/24/2017Not yet inspectedN/AN/AYes
Olympia Compounding Pharmacy, Orlando, FL3/10/201411/5/201612/4/2014YesWarning Letter - 2/4/2016Yes
Pacifico National dba Amex Pharmacy, Melbourne, FL9/21/201512/17/20161/21/2016YesOpenYes
Pentec Health, Boothwyn, PA9/21/201611/22/2016Not yet inspectedN/AN/AYes
Pharm D Solutions, LLC, Houston, TX8/6/201410/25/20166/5/2015YesWarning Letter - 12/8/2016Yes
Pharmaceutic Labs, LLC, Albany, NY3/10/201410/27/20169/23/2015YesWarning Letter - 5/3/2017Yes
PharMedium Services, LLC, Cleveland, MS
12/11/201310/11/20167/16/2015 Regulatory Meeting - 11/18/2016No
PharMedium Services, LLC, Dayton. NJ11/3/201510/11/20165/26/2016YesRegulatory Meeting - 11/18/2016No
PharMedium Services, LLC, Memphis, TN12/11/201310/17/20167/10/2015
Regulatory Meeting - 11/18/2016
No
PharMedium Services, LLC, Sugar Land, TX
12/11/2013
10/17/2016
9/24/2015
Yes 
Regulatory Meeting - 11/18/2016
No
Pine Pharmaceuticals, LLC, Tonawanda, NY6/17/201412/8/201610/9/2015YesWarning Letter - 11/7/2016Yes
Premier Pharmacy Labs Inc., Brooksville, FL4/16/201410/31/20166/13/2016YesOpen7Yes
Qualgen LLC, formerly registered as Amerilab LLC, Edmond, OK5/23/201411/8/20165/10/2017YesOpen7Yes
Queens Express Pharmacy, Jackson Heights, NY5/10/201610/14/20167/11/2016YesOpenYes
Quva Pharma, Inc., Sugar Land, TX9/10/201510/12/20166/2/2017YesOpen7No
QuVa Pharma, Inc., Temple, TX12/15/201510/12/201612/8/2016YesOpenYes
RAM Pharma, Inc. Idaho Falls, ID7/21/201612/19/20163/1/2017YesOpenYes
RC Outsourcing, LLC, Lowellville, OH10/6/201510/25/20163/31/2017YesOpen7Yes
Resource Optimization and Innovation, Springfield, MO9/22/201512/22/201611/29/2016YesOpenNo
Right Value Drug Store dba Carie Boyd's Prescription Shop, Hurst, TX1/11/201611/5/20165/12/2017YesOpen7Yes
RXQ Compounding LLC, Athens, OH1/2/201511/28/20169/21/2015YesWarning Letter - 5/19/2016Yes
SCA Pharmaceuticals, Little Rock, AR
12/13/2013
10/31/2016
4/1/2014
YesWarning Letter - 6/25/2015Yes
Seaview Enterprises, Los Alamitos, CA2/14/20172/14/2017Not yet inspectedN/AN/AYes
Sincerus Florida, LLC, Pompano Beach, FL3/10/201611/30/20166/29/2017YesOpen7Yes
SSM St. Clare Health Center, Fenton, MO2/18/201410/26/20168/14/2014YesWarning Letter - 10/19/2015No
STERRX, LLC, Plattsburgh, NY  5/29/2015 11/30/2016 3/17/2017Yes Open Yes 
Stokes Healthcare Inc, Mt. Laurel, NJ  6/28/2017 6/28/2017 Not yet inspected N/A N/A Yes 
Triangle Compounding Pharmacy, Inc., Cary, NC1/24/201411/21/2016 9/22/2014; 1/16/2015Yes (9/22/2014and 1/16/2015Warning Letter - 11/2/20157 Yes
US Compounding, Inc., Conway, AR12/20/201312/15/20167/15/2016YesResumed operations after cessation of sterile operations and recall of sterile products7Yes
US Specialty Formulations LLC, Bethlehem, PA
1/31/201410/27/20165/29/2015YesWarning Letter - 9/30/2016Yes
Wells Pharmacy, Inc., Dyersburg, TN6/7/20162/28/201710/20/2016YesRegulatory Meeting - 3/8/2017Yes

Notes

1.       The "initial date of registration as an outsourcing facility" is the date the facility was first registered (i.e., the date FDA determined that the initial registration information submitted for the facility was complete, and for firms first registering on or after October 1, 2014, the establishment fee was paid in full).
Under section 503B(b) of the FD&C Act, after the initial registration, a facility that elects to continue to be registered with FDA as an outsourcing facility must re-register annually. Beginning in fiscal year (FY) 2015 (October 1, 2014 to September 30, 2015), a facility that elects to register (or re-register) with FDA as an outsourcing facility must pay an annual establishment fee. The “date of most recent registration as an outsourcing facility” reflects the date FDA determined the most recently submitted registration information was complete and the annual establishment fee for that fiscal year paid in full. 
Unless a previously registered outsourcing facility re-registers and pays the annual establishment fee in full during the registration period (between October 1 and December 31 of each calendar year), the facility will be removed from the list of registered outsourcing facilities on January 1 of the next calendar year. 
2.       Inspections identified in this table are associated with the facility at the listed address. A company may own or operate more than one registered outsourcing facility. FDA’s web page Compounding: Inspections, Recalls, and Other Actions may contain information about compounding facilities under the same ownership as the listed registered outsourcing facility.
Inspections may take place over several days, weeks, or longer. The date of the inspection is the date a Form FDA-483 listing the investigators' observations was issued. If no FDA Form-483 was issued, the date is the last day of the inspection.
3.       A Form FDA-483 is issued when investigators observe any significant objectionable conditions. It does not constitute a final Agency determination of whether any condition is in violation of the FD&C Act or any relevant regulations. 
4.       This table does not include State Board of Pharmacy actions, if any. To determine whether a registered outsourcing facility has been the subject of a state enforcement action, check with the State Board of Pharmacy for the state in which the facility is located. Some states post disciplinary or other actions on their web sites.
5.       "Closed" means the inspection has been closed without further action. "Open" means that FDA has not made a determination as to whether further action will be taken. If an action has been taken, it will be listed. Possible FDA actions include: warning letter; seizure; or injunction.
6.       The information in this column was provided by the registered outsourcing facility at the time of registration and has not been verified by FDA. “N/A”, indicates the registered outsourcing facility has not provided this information. In the future, FDA intends to provide information about whether the outsourcing facility also intends to compound nonsterile drugs from bulk drug substances. That information is not currently available to the Agency.
7.       This facility was the subject of at least one previous inspection relating to compounding that resulted in a Form 483, warning letter, or other action. For information about such inspections and resulting actions, see Compounding: Inspections, Recalls, and other Actions
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