FDA Inspection 594627 — Allergan Sales LLC
The FDA completed an inspection of Allergan Sales LLC on July 10, 2009 in Cincinnati, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 10, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cincinnati, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |