The QMN Weekly Bulletin
Pharmaceuticals / Inspections and Audits

Chinese Manufacturer Cited for Failing to Disclose Information to FDA, Maintain GMP Standards in Warning Letter

Jan. 6, 2017

The FDA handed Baoying County Fukang a warning letter after the company’s management withheld information from the agency and failed to maintain methods and controls in compliance with GMP standards.

During a June inspection of the company’s Jiangsu facility, FDA investigators asked the company’s management to disclose the details of its microbiological testing processes, but the company official balked, saying he would not disclose trade secrets.

Additionally, the FDA cited the facility for not maintaining sanitary conditions. Investigators observed a black, mold-like material on the floors and walls, water on the floor and live insects at the entrance of a storage area for the company’s drugs.

Baoying also neglected to equip the location with adequate washing facilities, including hot and cold water. The only toilet at the facility, which is shared by production and quality personnel, had visible sewage and no running water, the FDA said.

Furthermore, the company failed to establish: an adequate quality control unit to approve or reject all drugs; an appropriate laboratory to determinate the satisfactory conformance to final specifications for the drug; and written procedures that describe in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of drug product containers and closures.

The FDA said the six observations in the warning letter landed the company on the import alerts list and placed a suspension on drug and supplement approvals until the company corrects the violations. The agency is requesting that the company specify what it has done since the inspection to rectify the deficiencies and to prevent their recurrence.

Everyone breathes a sigh of relief when the FDA investigators depart. But if they left behind a Form 483 pointing out deficiencies and noncompliances, that’s when the work really starts. This management report, Effective 483 Responses: Focus on CAPA Violations, will provide an insight into how to avoid 483s by implementing solutions others have used.

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