FDA Inspection 1142713 — San Antonio Fertility Center Laboratory, Inc
The FDA completed an inspection of San Antonio Fertility Center Laboratory, Inc on May 24, 2021 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 24, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- San Antonio, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12238 | 21 CFR 1271.55(b)(1) | Statement re: certified testing lab |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |