FDA Inspection 1240685 — California Cryobank LLC d.b.a. Cooper Surgical
The FDA completed an inspection of California Cryobank LLC d.b.a. Cooper Surgical on June 7, 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). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 7, 2024
- Fiscal Year
- 2024
- 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 |