March 13, 2012
2012-DAL-UTL-15
CERTIFIED MAIL:
RETURN RECEIPT REQUESTED
Thomas L. Bell, President and CEO
Sogeval Laboratories, Inc.
635 Fritz Drive, Suite 210
Coppell, TX 75019
Dear Mr. Bell:
During the May 9 through 20, 2011, inspection of your establishment at 635 Fritz Drive, Suite 210, Coppell, Texas, an investigator from the Food and Drug Administration determined that your firm is an own-label distributor of veterinary drug products. These products are drugs within the meaning of section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1)(B) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.
The above-stated inspection revealed that your firm's veterinary drugs are adulterated under section 501(a)(2)(B) of 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, packaging or holding fails to conform to, or is not operated or administered in conformity with Current Good Manufacturing Practice (CGMP) regulations as specified in Title 21, Code of Federal Regulations, Parts 210 and 211 (21 C.F.R Parts 210 and 211). No distinction is made between animal and human drugs, and the failure to comply with CGMP constitutes a failure to comply with the requirements of the Act.
In addition, our October 11 to November 4, 2011 inspection at Sogeval Laboratories, Incorporated, located at 4027 Tampa Road, Suite 3000, Oldsmar, Florida, identified numerous additional CGMP violations.
Please note that we have reviewed Ms. Lemaire's response dated June 2, 2011 in response to FDA's May 2011 inspection at Coppell, Texas and November 22, 2011 in response to FDA's October inspection in Oldsmar, Florida. We have included applicable comments following each item listed below.
The Coppell location
CGMP violations
Your firm distributes under its own label, drug products that are
manufactured for you by contract manufacturers. Your firm has responsibility for
complaint handling and additional quality control unit (QCU) functions. Your
firm's operations must satisfy the requirements of 21 C.F.R. §§ 211.198 and
211.22, but fail to do so. Specifically,1. Your firm's QCU failed to ensure a thorough investigation in accordance with 21 C.F.R. § 211.192 with conclusions and follow up accomplished as required by 21 C.F.R. § 211.198(a).
For example, the QCU failed to investigate or did not fully investigate complaints in numerous documented instances. Specifically, nineteen (19) consumer complaints were received by your firm from July 2009 to May 2011, for DUOXO Microcellular Cleaning Solution, DUOXO Spot-on, DUOXO Microcellular Solution, DUOXO Seborrhea Shampoo, and DOUXO Calm Emulsion Spray. The complaints included: animal ruptured ear drum, animal skin reactions, respiratory distress in humans, and a related human death. We have concluded your company did not conduct timely, comprehensive investigations. Your firm's management, including the QCU, was not proactive in response to consumer complaints. Quality problems must be thoroughly investigated, root cause determined, and appropriate corrective and preventive actions implemented. Furthermore, your firm does not have a written procedure for conducting investigations when complaints are received. We acknowledge your commitment to develop an SOP for complaint handling; however, your response is inadequate because you do not define a timeframe for completion or define what will be further developed in the SOP.
2. Your firm has failed to follow written responsibilities and procedures applicable to the QCU [21 C.F.R. § 211.22(d)].
Your firm does not have documentation addressing the basic roles, responsibilities, and procedures for your QCU. We acknowledge your commitment to develop an SOP to define the scope of responsibilities of the QCU; however, your response is inadequate because it fails to 1) describe changes that would be implemented in your procedures in the Quality Manual to ensure an effective QC process and, 2) include any analysis of the effectiveness of your procedure. We cannot assess the adequacy of the above corrective actions since the SOPs have not been submitted.
3. The QCU has not fulfilled its responsibility nor exercised its authority to approve or reject drug products manufactured, processed, packed, or held under contract by another company [21 C.F.R. § 211.22(a)].
For example, your firm has been an own-label distributor for contract manufactured veterinary drug products since 2008. However, only two audits have been conducted of these contract manufacturing firms since that time. Our inspection raises concerns about the effectiveness of the audits. Please comment on how future audits will ensure the QCU will identify and correct deficiencies and prevent recurrences. Further, your firm should have agreements in place with your contract manufacturers. We are also concerned about your firm's fundamental understanding of what is required of your QCU and the regulatory expectations to handle specific agreements that delineate responsibilities to each party (e.g., quality control responsibilities). Your firm is ultimately responsible for the quality of your products. Regardless of who manufactures your products, you are required to ensure these products meet predefined specifications prior to distribution and are manufactured in accordance with the Act, and its implementing regulations, including CGMP regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Part 211.
The Oldsmar facility
CGMP violations
1. Your firm's QCU failed to ensure a thorough investigation in accordance
with 21 C.F.R. § 211.192 with conclusions and follow up accomplished as required
by 21 C.F.R. § 211.198(a).For example,
a) Your firm failed to adequately investigate Adverse Event #2011-054, dated July 12, 2011, regarding human suffering an adverse reaction (asthmatic attacks) allegedly involving use of DOUXO Chlorhexidine PS Shampoo, lot# 003404.
b) Your firm failed to adequately investigate Adverse Event #2011-053, dated July 25, 2011, regarding human suffering adverse reaction (hives, breathing problems) allegedly involving use of PhytoVet P Anti-Itch Shampoo, lot #10911A.
c) Your firm conducted a recall of DOUXO Calm Shampoo 3L, lot # 006901, Exp 09/12, after product complaint of foul odor, dated September 1, 2011. A retain sample of this lot revealed microbial growth. However, no action was taken to determine cause of the microbial growth.
We have concluded that your company did not conduct timely, comprehensive investigations to numerous adverse events received at your distribution facility. Each investigation should include a root cause determination, corrective action plan, and evaluation of product impact.
We acknowledge in your response that you plan to further develop a new SOP for complaint investigation. However, your response is inadequate because you do not define a timeframe for completion or define what will be further developed in the SOP.
2. Your firm's written procedures to control issuance of labels are incomplete [21 C.F.R. § 211.125(f)] and your firm failed to conduct reconciliation between labels issued, used, and returned and product produced [21 C.F.R. § 211.125(c)].
For example,
a) Your firm's Labeling Control Procedure, SOP-OP501.01TR-R01-15-11, lacks information regarding control of issuance of labeling to drug product labeling operations.
b) Your firm does not document: 1) the quantity of labels issued to or returned unused from the production floor, 2) quantity of labels obtained for use or returned unused by each employee or for each production line and, 3) differences in quantity of labels found after (b)(4) inventory.
Your response stated the SOP will be revised to include label issuance details; however, the response failed to include what specific details will be included in the updated SOP. Furthermore, your response did not include the revised SOP.
3. Your firm has failed to follow written responsibilities and procedures applicable to the QCU [21 C.F.R. § 211.22(d)].
Your firm does not have documentation addressing the basic roles, responsibilities, and procedures for your QCU. We acknowledge your commitment to develop an SOP to define the scope of responsibilities of the QCU; however, your response is inadequate because it fails to 1) describe changes that would be implemented in your procedures in the Quality Manual to ensure an effective QC process and, 2) include any analysis of the effectiveness of your procedure. We cannot assess the adequacy of the above corrective actions since the SOPs have not been submitted.
Be advised that we will confirm the implementation and adequacy of all corrective actions upon reinspection of your facilities.
Neither this letter nor the observations noted in this letter are intended to be an all inclusive statement of deficiencies that may exist at your facilities. It is your responsibility to ensure that all facilities under your control comply with all of the requirements of the Act and the regulations promulgated under it.
We remind you that under Section 512 of the Act, 21
U.S.C. 360b, to be legally marketed new animal drugs require approved or
conditionally approved new animal drug applications, approved abbreviated new
animal drug applications, listings on the Index of Legally Marketed Unapproved
New Animal Drugs for Minor Species (Index Listings), or investigational
exemptions. We note that your firm markets its topical drug products without
approved applications, index listings, or investigational exemptions. You should
be aware that unapproved products that lack a required application or index
listing are subject to FDA enforcement action to remove them from the market at
any time. We also remind you that all drugs, whether marketed with approval or
not, must, among other things, be listed with the FDA by a registered firm;
manufactured according to CGMP; and have labels and labeling that meet the
requirements of the Act and its implementing regulations. You may obtain
information on the drug application approval process on our web page www.fda.gov/cvm1.
Please notify this office in writing, within 30 working days of receipt of
this letter, of the specific steps that you have taken to correct the noted
violations, including an explanation of each step being taken to prevent the
recurrence of similar violations. If corrective actions cannot be completed
within 30 working days, state the reason for delay and provide timeframes or a
schedule detailing when these corrections will be completed.
Your reply should be sent to the Food and Drug
Administration, Dallas District Office, 4040 North Central Expressway, Suite
300, Dallas, Texas 75204, to the attention of Rose Ashley, Compliance Officer.
If you have any questions about the content of this letter please contact Rose
Ashley at (210) 541-9450, Ext. 1118 or email at Rose.Ashley@fda.hhs.gov.
Sincerely,/s/
Reynald R. Rodriguez, Jr.
Dallas District Director
RRR/rma
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