FDA 483 - Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company - February 13, 2026
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company in Manati, PR, received a Form 483 citing significant quality control deficiencies during an inspection from January to February 2026. Observations included ineffective corrective actions for foreign particulates in sterile drug products, inadequate investigation of product quality complaints, and insufficient reserve samples for testing. Additionally, the firm failed to follow procedures to prevent microbiological contamination, indicating a moderate level of non-compliance.
- Inspection Date
- February 13, 2026
- Product Type
- Drugs
ID · 473e5d65-fa74-4039-931e-190b8cca243e