FDA Inspection 1199861 — Alabama Fertility Specialists, PC
The FDA completed an inspection of Alabama Fertility Specialists, PC on March 15, 2023 in Homewood, AL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 15, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Homewood, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12238 | 21 CFR 1271.55(b)(1) | Statement re: certified testing lab |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |