FDA Inspection 966871 — Allergan Sales, LLC
The FDA completed an inspection of Allergan Sales, LLC on Jan 15, 2016 in Irvine, CA. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 15, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Irvine, CA (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |