FDA Inspection 1266609 — Global Premier Fertility Orange County LLC
The FDA completed an inspection of Global Premier Fertility Orange County LLC on Apr 11, 2025 in Newport Beach, 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
- Apr 11, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Newport Beach, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12238 | 21 CFR 1271.55(b)(1) | Statement re: certified testing lab |
| 12242 | 21 CFR 1271.55(c) | Name and personal info on accompanying records |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |