Drugs

Multiple Violations at Generitech

David McFarland

— 1 min read
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A 7/6-7/28/21 FDA inspection at Generitech Corp., Fresno, CA, found significant violations of current good manufacturing practice (CGMP) regulations and unapproved new drug and misbranding violations. A just-released 3/1 Warning Letter lists specific CGMP violations as: 

  •          failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
  •          failing to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failing to validate and establish the reliability of the component supplier’s test analyses at appropriate intervals;
  •          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 clean, maintain and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

The letter says two of the firm’s products are unapproved new drugs that are misbranded. It also says the firm’s inspection history and the significant findings in the Warning Letter indicate that its quality unit is not fully exercising its authority and/or responsibilities.

FDA says that a 4/5/13 inspection and 1/24/12 notice of violation raised similar CGMP observations and violations. “You proposed specific remediation for these observations and violations in your response,” the agency says. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”

FDA strongly recommends that the firm retain a qualified consultant to assist it in meeting CGMP requirements.

Generitech’s response to the FDA-483 inspection observations was inadequate because it did not provide sufficient detail or evidence of corrective actions to bring the operations into CGMP compliance, the letter says.

The firm was told to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with a schedule for completing the corrective actions.

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