FDA Inspection 1114658 — Brown Fertility Associates, PA
The FDA completed an inspection of Brown Fertility Associates, PA on January 9, 2020 in Jacksonville, FL. 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
- January 9, 2020
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Jacksonville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12242 | 21 CFR 1271.55(c) | Name and personal info on accompanying records |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |