Warning Letter of the Week: secrets, mold and toilets edition

A cordial note from the FDA Center for Drug Evaluation and Research to Mr. Yikai Fu, the general manager of

Baoying County Fukang Medical Appliance Co., Ltd, pointing out a few problems with their facility: 

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 [redacted] 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....

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 [redacted] used in the production of your firm’s [redacted]. 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.

Count me as a bit surprised that the CFR lays out the requirements for a toilet facility at a cGMP plant, but there it is! Huh.