FDA Inspection 1255573 — Repro Lab, Inc.
The FDA completed an inspection of Repro Lab, Inc. on November 19, 2024 in New York, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 19, 2024
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12283 | 21 CFR 1271.75(e) | Abbreviated procedure |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |