FDA Inspection 1116246 — American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc.
The FDA completed an inspection of American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc. on January 22, 2020 in Irvine, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 22, 2020
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12235 | 21 CFR 1271.55(a)(1) | Personal information included in I.D. code |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |