Drugs

CGMP Violations at BioDiagnostic International

A 1/31-2/27 FDA inspection at BioDiagnostic International, Brea, CA, found significant violations of the Federal Food, Drug, and Cosmetic Act and of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. Specific violations cited in a 7/12 Warning Letter were:

failing to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups;
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 for each batch of drug product required to be free of objectionable microorganisms, appropriate laboratory testing, as necessary;
failing to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance; and
failing to establish a 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.

FDA says that based on the nature of the violations, it strongly recommends that the company engage a qualified consultant to evaluate the entire operation for CGMP compliance and then assist it in meeting requirements. The letter acknowledges the firm’s recall of all unidentified drug product batches that were within expiration after multiple discussions with FDA, and asks the company to clarify whether it intends to recommence manufacture of any drugs at this facility in the future. The agency also says it appears that the firm is distributing an unapproved prescription drug.

BioDiagnostics 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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