FDAnews Drug Daily Bulletin

FDA Calls Out Two Manufacturers Over GMP Violations

May 10, 2016

The FDA is accusing two companies — one a dietary supplement manufacturer and one an API maker — of committing a multitude of GMP violations.

In an April 15 letter to Pacific Nutritional, the FDA accused the company of producing four adulterated dietary supplements based on a host of GMP failures.

Those purported GMP failures included an inadequate process and master manufacturing record, failure to establish proper finished product specifications, a lack of quality control procedures and a failure to establish and follow proper laboratory control processes.


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