FDA Inspection 1239352 — American CryoStem Corporation
The FDA completed an inspection of American CryoStem Corporation on May 22, 2024 in Monmouth Junction, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 22, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Monmouth Junction, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12359 | 21 CFR 1271.195(a)(3) | Aseptic processing---cleaning, disinfecting |
| 12375 | 21 CFR 1271.210(a) | Use prior to verification |