FDA Inspection 1253861 — Barr Laboratories, LLC.
The FDA completed an inspection of Barr Laboratories, LLC. on May 9, 2025 in Forest, VA. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 9, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Forest, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |