FDA Issues 5 Warning Letters Over GMP Violations

The FDA has sent out five warning letters related to GMP violations at drug facilities in America, China and India.

College Pharmacy, based in Colorado, and Cape Apothecary, in Maryland, were both cited as investigators observed serious deficiencies in their practices for producing sterile drug products.

According to the FDA, Frontida BioPharm in Pennsylvania failed to ensure that cGMP-related records, including reports containing data and documentation from unrelated investigations, were properly recorded and filed.

FDA found significant cGMP violations at the Huzhou Aupower Sanitary Commodity plant in China, including lack of appropriate laboratory determination of satisfactory conformance to final specifications for the drug products.

Unimark Remedies in India failed purity tests during manufacturing, although its records say it passed the tests.