FDA Inspection 1268783 — Advanced Fertility Associates Medical Group, Inc.
The FDA completed an inspection of Advanced Fertility Associates Medical Group, Inc. on May 1, 2025 in Santa Rosa, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 1, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Santa Rosa, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12231 | 21 CFR 1271.50(b)(1) | Donor screening standards |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |