FDA Inspection 774675 — UT Health San Antonio Reproductive Health and Fertility Center
The FDA completed an inspection of UT Health San Antonio Reproductive Health and Fertility Center on March 28, 2012 in San Antonio, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 28, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- San Antonio, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12236 | 21 CFR 1271.55(a)(2) | Eligibility statement--basis of determination |
| 12240 | 21 CFR 1271.55(b)(3) | Name and address on summary |