Inspections, Compliance, Enforcement, and Criminal Investigations
Diversified Manufacturing Corporation 20-Oct-05
Department of Health and Human Services
Public Health Service
Minneapolis District Office
October 20, 2005
RETIIRN RECEIPT REQUESTED
Refer to MIN 06 - 09
Diversified Manufacturing Corporation
101 Seventh Avenue
Newport, MN 5.5055
Dear Mr. Motilall:
On March 4,7 and 10, 2005, the Food and Drug Administration (FDA) conducted an inspection of your human and animal product manufacturing facility in Newport, Minnesota. Our investigator found your firm manufactures a variety of products, including human over-the-counter (OTC) drug products (SPF lotions, dandruff shampoo, waterless hand sanitizers, etc.), animal drug products (medicated shampoos for horses, etc.) and industrial products (liquid fungicides, insecticides, engine degreasers, floor cleaners, etc.).
The inspection revealed significant deviations from U.S. Current Good Manufacturing Practice (CGMP) Regulations [Title 21, Code of Federal Regulations (21 CPR), Parts 210 and 211] in the manufacturing of your OTC human drug -products. The CGMP violations cause these products 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)]. These violations include, but are not limited to:
Failure to validate cleaning of the equipment and to maintain records of maintenance, cleaning, sanitizing and inspection of equipment. Specifically, because the mixing vessels are not dedicated and records of cleaning are not maintained, there is no assurance that mixing vessels used for industrial chemicals are not also used for drug product manufacturing. Furthermore, because there is no cleaning validation, there is no assurance that drug products are not tontamiti.ated with industrial chemicals. [21 CPR 211.67(a)]
Failure to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, prior to release. Specifically, finished drug products are never tested for identity and strength prior to re1ease and distribution. [211.165(a)]
Failure to withhold from use each lot of components, drug product containers and closures until the lot has been sampled, tested, examined, and released by the quality control unit. Failure to conduct at least one specific identity test and establish the reliability of the supplier's analyses. Specifically, your firm does not complete any raw material testing for any raw material received, including both active and inactive ingredients. In addition, although your firm receives a Certificate of Analysis (CoA) from the component supplier, you do not conduct a specific identity test on components and have not verified the supplier's CoA. [2I CFR 211.84(a) and (d)]
Failure to thoroughly investigate failures of finished drug products or drug product components to meet established specifications. Specifically, finished product samples that test positive for microbial growth are retested on new media; no investigation into the first positive result is conducted, as required. [21 CFR 211.192]
Failure to properly identify each lot of drug components of its status in terms of being quarantined, approved, or rejected. Specifically, several containers of raw materials were observed in use that bore only the "Quarantine" sticker. [21 CPR 211.80(d)]
Failure to have written procedures for stability testing and to perform stability. testing for drug products. [21 CFR 211.166]
Failure of the drug product to bear an expiration date determined by appropriate stability testing. [21 CFR 211.137(a)]
The [redacted] Dandruff and Deodorizing Shampoo is misbranded under Section 502(c) of the Act [21 U.S.C. 352(c)] because it fails to bear the Drug Facts Format labeling required by 21 CFR 201.66.
The labeling and CGMP violations described above or on the FDA-483 are not to be considered all-inclusive. It is your responsibility to ensure that all drug products manufactured by your firm are in compliance with the Act. We request that you take prompt action to correct these violations. Failure to correct these violations may result in regulatory action without further notice such as seizure and/or injunction.
Please notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken to correct the stated violations; including an explanation of each step taken to identify and make corrections to assure that similar violations will not reoccur. If corrective action can not be implemented within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed.
Your reply should be directed to Compliance Officer Judy E. Heisick at the address indicated on the letterhead. Ms. Heisick can be reached at (612) 758-7118.
W. Charles Becoat