FDA Inspection 601811 — California Cryobank LLC
The FDA completed an inspection of California Cryobank LLC on August 7, 2009 in Los Angeles, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 7, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Los Angeles, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12319 | 21 CFR 1271.160(b)(3) | Actions taken and documented |
| 12359 | 21 CFR 1271.195(a)(3) | Aseptic processing---cleaning, disinfecting |
| 12364 | 21 CFR 1271.195(c) | Monitoring-microorganisms where appropriate |
| 12376 | 21 CFR 1271.210(b) | Use of non-sterile reagents |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |