FDA Inspection 654640 — Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company
The FDA completed an inspection of Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company on March 31, 2010 in Manati, PR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 31, 2010
- Fiscal Year
- 2010
- 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 |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |