FDA Inspection 1055373 — ART Fertility Program of Alabama
The FDA completed an inspection of ART Fertility Program of Alabama on June 5, 2018 in Birmingham, AL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 5, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Birmingham, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |