Drugs

Cadila Healthcare CGMP Violations

A 4/22-5/3 FDA inspection at Cadila Healthcare, Ahmedabad, India, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. A 10/29 Warning Letter lists the specific violations as:

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;
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 follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes;
failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

The letter acknowledges a 10/2 communication informing the agency that the company would permanently cease production of injectable drug products for the U.S. “It is important to note that full remediation of the related CGMP violations cited will be necessary if you decide to resume the manufacturing of injectable drug products at this site, or if any successor firm assumes responsibility over the site’s operation in the future,” it says.

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

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