FDA Inspection 841121 — Lilly Del Caribe, Inc
The FDA completed an inspection of Lilly Del Caribe, Inc on Jul 22, 2013 in Carolina, 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 22, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Carolina, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 17749 | 21 CFR 212.30(a) | Prevention of contamination |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 8907 | 21 CFR 314.81(b)(1)(ii) | Contamination, chemical or physical change, deterioration |