FDA Inspection 993014 — Bristol-Myers Squibb Manufacturing Company Unlimited Company
The FDA completed an inspection of Bristol-Myers Squibb Manufacturing Company Unlimited Company on November 18, 2016 in Humacao, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 18, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Humacao, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |