GMP violations with respective to cGMP Practices @ FDA Warning letter

The U.S. Food and Drug Administration (FDA) inspected Chinese firm M/s Baoying County Fukang Medical Appliance Co. revealed serious 6 GMP Violations. Details as below

Our investigators documented that your firm limited and/or refused an FDA inspection. Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), section 707, 21 U.S.C. 351(j), your drug products are adulterated in that they have been manufactured, processed, packed, or held in an establishment where the owner or operator has limited inspection and refused inspection.

FDA investigators has documented that the firm has refused limited access to audit and firm having methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP.

This warning letter summarizes an inspection and significant deviations from CGMP for drug manufacturing.

1.    Your firm delayed, denied, or limited an inspection, or refused to permit the FDA inspection.

On June 6, 2016, during the inspectional walk through of the laboratory testing area of your facility, our investigator asked you to explain the microbiological testing processes used on the (b)(4) that you manufacture and distribute to the United States. Your firm’s representative stated he would not disclose the firm’s trade secrets. Our investigator explained that as part of the inspection, FDA needs to know the details of the operations, and that FDA does not disclose details of the information. Nonetheless, without reasonable explanation, the full test procedure was never provided.

Your firm limited the inspection by refusing to disclose the manufacturing process you use in your facility to conduct microbiological testing on (b)(4). You may wish to review FDA’s guidance document, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection, at http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm360484.pdf

2.    Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products. (21 CFR 211.22(a))    

During the investigation, our investigator found your firm has no written procedures for production or quality unit responsibilities. Among other things, your quality unit approved and released (b)(4) and (b)(4) for distribution to the U.S. market. Your firm approved these products for release even though your quality unit had no assurance that they met specifications or that they were manufactured under adequate controls.

3.    Your firm does not have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. (21 CFR 211.165(a))

Your firm manufactures (b)(4) labelled “For (b)(4).” Your firm stated to the investigator that you do not perform microbiological analysis of your final products prior to release to the U.S. market. In addition, you informed our investigator that you do not perform assay testing for your over-the-counter (OTC) drug products to verify the identity and strength of the active ingredients prior to release. Your firm also failed to provide requested records for chemical analyses performed for products released to the U.S. market.

4.    Your firm failed to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition and to keep them free of infestation by rodents, birds, insects, and other vermin. (21 CFR 211.56(a))

Our investigator documented copious amounts of unknown black, mold-like material on the floor and walls of warehouse #2. In addition, our investigator observed standing water on the floor and live insects at the entrance of the same warehouse. This warehouse is a storage area for (b)(4) used in the production of your firm’s (b)(4). The poor conditions in your facility could compromise the quality of the products you manufacture.

5.    Your firm failed to provide adequate washing facilities, including hot and cold water, soap or detergent, air driers or single service towels, and clean toilet facilities easily accessible to working areas. (21 CFR 211.52)

There was no adequate washing facility accessible to working areas at your site. Additionally, the only toilet facility on-site contained visible sewage and had no running water. This toilet facility is shared by production, quality, and administrative personnel at your facility.

6.    Your firm failed to establish and follow written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures. (21 CFR 211.80(a))

Specifically, your firm receives drums of (b)(4) raw material from your supplier without any identifying labels. Your firm does not perform identity testing or any other analysis onincoming raw materials upon receipt or prior to use, and you have no procedure that permits you to trace the source of the (b)(4) in each batch of finished products.

Source: Warning Letter for Baoying County Fukang Medical Appliance Co. Ltd. 

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