FDA Inspection 960804 — Reproductive Institute of South Texas
The FDA completed an inspection of Reproductive Institute of South Texas on January 7, 2016 in Mcallen, 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
- January 7, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Mcallen, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12271 | 21 CFR 1271.65(b)(2) | Prominently labeled (limited use) |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |