Drugs

CGMP Issues at China’s Foshan Flying Medical

David McFarland

— 1 min read
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A 2/20-23/17 FDA inspection at Foshan Flying Medical Products, Foshan City, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to an 8/1 Warning Letter. Specific violations cited were: 

  •          failing to establish an adequate quality control unit and procedures applicable to the quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products;
  •          failing to perform, 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, and to conduct appropriate laboratory testing for each batch of drug product required to be free of objectionable microorganisms;
  •          failing to have, for each batch of drug product purporting to be sterile and/or pyrogen-free, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product;
  •          failing to establish written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess;
  •          failing to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced, and to maintain such records for at least one year after the expiration of the batch; and
  •          failing to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions.

FDA says that because of the nature of the violations identified at the firm, it strongly recommends that Foshan engage a qualified consultant to assist it in meeting CGMP requirements. The company was placed on import alert 5/23.

Foshan was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.

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