Warning letter
American Fertility Medical Center, Genetic Infertility & Andrology Lab: warning letter of Apr 2, 2020
FDA warning letter 605068 · Division of Biological Products Operations II
Key facts
| Reference number | 605068 |
|---|---|
| Company | American Fertility Medical Center, Genetic Infertility & Andrology Lab |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Apr 2, 2020 |
| Posted date | Apr 14, 2020 |
| Issuing office | Division of Biological Products Operations II |
| Product type | Biologics |
| CFR sections cited | 1271.80(d), 1271, 1271.155, 1271.3(s), 1271.47(a), 1271.55(a)(3), 1271.85(b)(2), 1271.50(a), 1271.55(d)(2), 1271.60(a), 1271.75(a), 1271.85(a) and 2 more |
| Inspection city | Irvine |
| Inspection ZIP | 92618 |
| Inspection start date | Jan 14, 2020 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: