FDA EIR - Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company - July 12, 2021

An FDA inspection of Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company in Manatí, PR, was conducted from May 11 to July 12, 2021. This for-cause, full Good Manufacturing Practices (GMP) inspection covered sterile drug products and combination products, adhering to Compliance Programs 7356.002A, 7356.002, 7356.002M, and 21 CFR Part 4/21 CFR 820 Device Regulations for combination products. The inspection revealed nine objectionable conditions, documented in an FDA-483 form. Key issues included numerous unreviewed and incomplete electronic and paper records, often missing critical data like results or incubation times. Microbiological quality control deficiencies were noted, such as prolonged incubation of media plates and cracked plates from aseptic areas. Product quality concerns involved foreign particles in sterile components and recurrent pest presence in production areas. Furthermore, autoinjector components were improperly stored in uncontrolled conditions, and deviation records lacked clear root causes and adequate corrective actions. There was also a failure to monitor essential design outputs for autoinjectors before release. Two verbal observations concerned particle identification and incomplete investigation data. Management committed to providing a written response within 15 working days, with the FDA warning of potential legal sanctions for uncorrected violations.