FDA Inspection 1263654 — Red Star Contract Manufacturing, Inc.
The FDA completed an inspection of Red Star Contract Manufacturing, Inc. on March 13, 2025 in Larwill, IN. 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
- March 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 |