Drugs

CGMP Consultant Recommended for Cellex-C

FDA is recommending that Cellex-C, a Toronto, Canada, drug manufacturer, retain a consultant to help it meet current good manufacturing practice (CGMP) regulations following a 1/16-1/19 agency inspection that found significant violations of the regulations. Specific violations listed in an agency 8/2 Warning Letter were:

failing to 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;
failing to test samples of each component for conformity with all appropriate written specifications for identity, purity, strength, and quality;
failing to establish written responsibilities and procedures applicable to the quality control unit;
failing to establish adequate 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; and
failing to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced.

The letter says the firm’s responses to the inspection observations were inadequate. “Based upon the nature of the violations we identified as your firm,” the letter says, “we strongly recommend engaging consultant qualified … to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance.”

FDA says the company was placed on an import alert 6/2. Cellex-C was told to respond with a list of steps it took since the inspection to correct the violations and prevent their recurrence, along with a timetable for completion.

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