755483
Alta Bates IVF Program — FEI 3004740532
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 2, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Berkeley, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12239 | 21 CFR 1271.55(b)(2) | Listing and interpretation of CD tests performed |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12270 | 21 CFR 1271.65(a) | Improper release prevention--storage, I.D. |
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |