FDA Inspection 814880 — Brown Fertility Associates, PA
The FDA completed an inspection of Brown Fertility Associates, PA on January 28, 2013 in Jacksonville, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 28, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Jacksonville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 15026 | 21 CFR 1271.85(c) | Reproductive cells or tissues-cell-associated CD |