FDA Inspection 1263654 — Red Star Contract Manufacturing, Inc.
The FDA completed an inspection of Red Star Contract Manufacturing, Inc. on Mar 13, 2025 in Larwill, IN. 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: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 13, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Larwill, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12411 | 21 CFR 1271.260(a) | Contamination, mix ups, improper release |
| 12417 | 21 CFR 1271.260(e) | Periodic review of temperatures |