Recalled Paracetamol, a question for CMC gurus [Off Topic]

posted by nobody – 2019-06-28 09:51  – Posting: # 20365
Views: 1,670

PPS:

The FDA found termites, dead pests, impurities and other serious GMP violations at Bristol-Myers Squibb’s drug facility in Manati, Puerto Rico, during a Jan. 15-Feb. 6 inspection.

The agency investigators discovered that a media fill conducted at the facility resulted in a vial that was murky and contaminated with bacteria. The firm identified the contaminants as mites. As a result, lots of lyophilized drug products were placed on hold.

Kindest regards, nobody

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