Drugs

Legacy Pharmaceutical CGMP Violations

A 4/12-4/27 FDA inspection at the Legacy Pharmaceutical Packaging drug manufacturing facility in Earth City, MO, identified significant violations of current good manufacturing practice (CGMP) regulations. A 10/3 Warning Letter says the specific violation was 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.

The letter also describes insanitary conditions resulting in adulterated drugs.

FDA acknowledges the company has engaged a consultant to assist it in meeting CGMP requirements. It says the consultant should also perform a comprehensive audit of the firm’s entire operation for CGMP compliance and evaluate the completion and efficacy of its corrective and preventive actions before Legacy pursues resolution of its compliance status with the agency.

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

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