FDA Inspection 1173190 — Center for Reproductive Health Fertility Laboratory of Nashville
The FDA completed an inspection of Center for Reproductive Health Fertility Laboratory of Nashville on June 30, 2022 in Nashville, TN. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 30, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Nashville, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12224 | 21 CFR 1271.47(c) | Availability of procedures |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |
| 12238 | 21 CFR 1271.55(b)(1) | Statement re: certified testing lab |
| 12239 | 21 CFR 1271.55(b)(2) | Listing and interpretation of CD tests performed |