FDA Inspection 1019153 — Center for Reproductive Health Fertility Laboratory of Nashville
The FDA completed an inspection of Center for Reproductive Health Fertility Laboratory of Nashville on July 21, 2017 in Nashville, TN. 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 21, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Nashville, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12236 | 21 CFR 1271.55(a)(2) | Eligibility statement--basis of determination |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |