FDA 483 - Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company - November 19, 2019
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An FDA inspection of Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company in Manati, PR, a sterile drug product manufacturer, revealed multiple significant deficiencies. These included failures in preventing microbiological contamination, inadequate laboratory record-keeping, and a deficient quality control unit. The facility also suffered from pest infestations and lacked proper written procedures for production and process controls, indicating systemic issues impacting drug product quality and purity.
- Inspection Date
- November 19, 2019
- Product Type
- Drugs
ID · 1a7ca172-8509-4f22-b87f-30ac950c30a1