Inspections, Compliance, Enforcement, and Criminal Investigations
Emtech Laboratories, Inc. 06-Mar-2003
Department of Health and Human Services
Public Health Service
Atlanta District Office
March 6, 2003
VIA FEDERAL EXPRESS
William L. Embry
Emtech Laboratories, Inc.
580 Cemetery Street
Norcross, Georgia 30071
Dear Mr. Embry:
Investigator D. Ross Spears of this office conducted an inspection of your drug manufacturing facility between January 27 and February 4, 2003. The inspection covered the manufacture of your antibacterial hand soap, DERMA CARE. This product is a drug as defined in Section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection revealed several significant deviations from the Current Good Manufacturing Practice for Finished Pharmaceuticals (CGMPs) under Title 21 of the Code of Federal Regulations Part 211 (21 CFR 211). These CGMP deviations, described below, cause your drug product to be adulterated under section 501(a)(2)(B) of the Act.
You have failed to conduct appropriate laboratory determinations to assure conformance to final specifications for each batch of drug product. This testing must include the identity and strength of each active ingredient, prior to release of the finished batch of drug product [21 CPR 211.165(a)]. You have failed to establish formal finished product release specifications. You could provide no analytical data for the active ingredient in any batch of drug product manufactured and released at your firm. In fact, your firm does not have equipment capable of conducting assays of the active ingredient. The only testing reportedly conducted on finished product is a pH check and labeling examination. No records are maintained of this review.
You have failed to assure that each lot of components used in your drug product meet appropriate specifications for purity, strength and quality prior to use [21 CFR 211.84]. No analytical testing is performed on any incoming component used in the formulation of your drug product. No certificates of analysis are required for incoming components. Incoming raw materials are reportedly accepted for use based solely, on a visual examination although no, records are maintained. You have failed to establish that municipal water, your predominant drug ingredient, is of appropriate chemical and microbiological quality. You have failed to conduct any evaluation of your components or your finished product to determine the need for microbiological testing [21 CFR 211.113(a)].
You have failed to establish and validate any written procedures for the cleaning of all equipment used in the manufacture of your drug product [21 CFR 211.67(a) and (b)]. No validation has been conducted to assure that previous products and cleaning agents have been adequately removed from equipment prior to reuse. This is of particular concern in that pharmaceutical products and other non-pharmaceutical products could be manufactured in common equipment.
You have failed to ensure that each pawn engaged in the manufacture, processing, packing, or holding of your drug product, and each person responsible for supervising these activities, has the education, training, and experience to enable that person to perform their assigned functions in such a manner as to provide assurance that your drug product has the quality and purity that it purports to or is represented to possess [21 CFR 211.25(a) and (b)]. This training must not only be in the particular operations that the employee performs but also include current good manufacturing practice as it relates to the employee's functions. No one at your firm has received training commensurate with their responsibilities. You stated to our investigator that you were aware of CGMPs but did not know that they related to the drug product you manufactured. Investigator Spears provided you with a copy of the applicable regulations from the CFR. This lack of training was exemplified by your firm's total lack of compliance with the applicable regulations for the manufacture of drug products.
The violations described above are not meant to be all-inclusive. It is your responsibility to ensure that all drug products manufactured and distributed by your firm comply with the Act. Federal agencies are advised of the issuance of all Warning Letters pertaining to drugs so that they may take this information into account when considering the award of contracts. In addition, any pending New Drug Applications, Abbreviated New Drug Applications, or export certificate requests submitted by your firm may not be approved until the above violations are corrected. The CGMP deviations, described above, were included on the Inspectional Observations (FDA 483) which was issued and discussed with you at the conclusion of the inspection. We request that you take action immediately to correct these violations. Failure to do so may result in regulatory action without further notice, including seizure and/or injunction.
Please respond to this, office in writing within fifteen (15) working days of receiving this letter. Your response should describe the specific, actions you will take, or have taken, to correct the violations described above. It should also include an explanation of each step being taken to prevent recurrence of similar violations. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which corrections will be completed. Your response should be sent to Philip S. Campbell, Compliance Officer, at the address noted in the letterhead. If you wish to discuss this letter or our continuing concerns with your facility should contact Mr. Campbell at (404) 253-1280.
Mary H. Woleske, Director