Warning letter
University of Miami Reproductive and Fertility Center: warning letter of Dec 3, 2018
FDA warning letter 568208 · Center for Biologics Evaluation and Research
Key facts
| Reference number | 568208 |
|---|---|
| Company | University of Miami Reproductive and Fertility Center |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Dec 3, 2018 |
| Posted date | Dec 25, 2018 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Biologics |
| CFR sections cited | 1271, 1271.75, 1271.75(a)(1), 1271.90(c)(4)(ii), 1271.3(h), 1271.50(a) |
| Inspection city | Miami |
| Inspection ZIP | 33136 |
| Inspection start date | Jul 10, 2018 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 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: