FDA Inspection 1086054 — ALLERGAN SALES, LLC
The FDA completed an inspection of ALLERGAN SALES, LLC on Apr 11, 2019 in Madison, NJ. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 11, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Madison, NJ (United States)
Additional details
Risk Evaluation and Mitigation Strategies (REMS)
Citations
| ID | CFR | Description |
|---|---|---|
| 21352 | FDCA 505-1(e)(2)(A) | Failure to comply with REMS Medication Guide |
| 21360 | FDCA 505-1(f)(4) | Failure to comply with REMS Implementation System |