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.
Particles—such as rubber, glass, hair and epoxy—were cited in complaints the firm received for aseptically filled drugs in vials. BMS said the suppliers of the primary components were the source of the contaminants.