FDA Inspection 715165 — AbbVie Ltd
The FDA completed an inspection of AbbVie Ltd on March 14, 2011 in Barceloneta, 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
- March 14, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Barceloneta, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |