FDA Inspection 1147009 — Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company
The FDA completed an inspection of Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company on July 12, 2021 in Manati, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 12, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Manati, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |