FDA - Warning Letter

11th August 2025

FDA - Warning Letter

A warning Letter from the FDA has been published, criticising the root cause analysis that was carried out. In a letter to Glenmark Pharmaceuticals (India).

The FDA highlighted that Glenmark's investigations lacked sufficient scientific evidence to identify the root causes of these failures. Additionally, the agency noted that similar issues had been observed at other Glenmark facilities in the past, raising concerns about the company's overall manufacturing practices. The FDA has requested that Glenmark provide a comprehensive corrective action plan to address these deficiencies.

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