Warning letter
California IVF Fertility Center: warning letter of Feb 26, 2020
FDA warning letter 598552 · Office of Biological Products Operations - Division II
Key facts
| Reference number | 598552 |
|---|---|
| Company | California IVF Fertility Center |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Feb 26, 2020 |
| Posted date | Mar 24, 2020 |
| Issuing office | Office of Biological Products Operations - Division II |
| Product type | Biologics |
| CFR sections cited | 1271.75, 1271.80, 1271.155, 1271.3(s), 1271.47(a), 1271.3(r), 1271.3(r)(2), 1271.60(a), 1271.85(a), 1271.75(a), 1271.90(b), 1271.90(c) and 1 more |
| Inspection city | Sacramento |
| Inspection ZIP | 95833 |
| Inspection start date | Oct 4, 2019 |
| 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: