FDA Inspection 1171593 — 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 Jun 9, 2022 in Irvine, 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). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 9, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |