FDA Inspection 1017589 — Alabama Fertility Specialists, PC
The FDA completed an inspection of Alabama Fertility Specialists, PC on May 4, 2017 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
- May 4, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Homewood, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |