FDA Inspection 1246440 — Williams OB/GYN & Associates
The FDA completed an inspection of Williams OB/GYN & Associates on August 12, 2024 in San Dimas, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 12, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- San Dimas, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12252 | 21 CFR 1271.60(a) | Completion of eligibility determination |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |