FDA Inspection 1176463 — Tennessee Reproductive Medicine
The FDA completed an inspection of Tennessee Reproductive Medicine on Aug 4, 2022 in Chattanooga, 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)
- End Date
- Aug 4, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Chattanooga, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |