FDA Inspection 1210976 — Texas Tech University Health Sciences Center Center for Fertility and Reproductive Surgery
The FDA completed an inspection of Texas Tech University Health Sciences Center Center for Fertility and Reproductive Surgery on July 26, 2023 in Lubbock, 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
- July 26, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Lubbock, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |
| 12252 | 21 CFR 1271.60(a) | Completion of eligibility determination |
| 12287 | 21 CFR 1271.80(c) | Kits not FDA approved, specifically labeled |