FDA Inspection 1250057 — Brown Fertility Associates, PA
The FDA completed an inspection of Brown Fertility Associates, PA on September 25, 2024 in Jacksonville, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 25, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Jacksonville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12239 | 21 CFR 1271.55(b)(2) | Listing and interpretation of CD tests performed |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |