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Pii Gets Positive Inspection News from FDA and MHRA

Previously restricted GMP Certificate withdrawn based on recent inspections by the FDA

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By: Kristin Brooks

Managing Editor, Contract Pharma

Pharmaceutics International, Inc. (Pii), a CDMO based in Hunt Valley, MD, received notification from the Medicines and Health Care products Regulatory Agency (MHRA) that the previously restricted GMP Certificate would be withdrawn based on the Mutual Recognition Agreement (MRA) and recent inspections conducted by the FDA. The notification said, “following confirmation from the U.S. FDA, Pii sites at Hunt Valley (Pii1) and Cockeysville (Pii3) and associated laboratories and storage facil...

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