FDA Inspection 861404 — Dallas Fertility Center-Baylor LLC
The FDA completed an inspection of Dallas Fertility Center-Baylor LLC on Jan 3, 2014 in Dallas, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 3, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12232 | 21 CFR 1271.50(b)(2) | Donor testing not negative for CD agents |
| 12238 | 21 CFR 1271.55(b)(1) | Statement re: certified testing lab |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |