FDA Inspection 565032 — Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company
The FDA completed an inspection of Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company on Mar 27, 2009 in Manati, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 27, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Manati, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3594 | 21 CFR 211.110(d) | Rejected in-process materials not quarantined |