FDA 483 - Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company - November 19, 2019

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.