Warning letter
Mark S. Denker, M.D., PA dba Palm Beach Fertility Center: warning letter of Nov 17, 2022
FDA warning letter 643090 · Division of Biological Products Operations I
Key facts
| Reference number | 643090 |
|---|---|
| Company | Mark S. Denker, M.D., PA dba Palm Beach Fertility Center |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Nov 17, 2022 |
| Posted date | Feb 7, 2023 |
| Issuing office | Division of Biological Products Operations I |
| Product type | Biologics |
| CFR sections cited | 1271, 1271.75, 1271.155, 1271.47(a), 1271.55(b)(2), 1271.55(d)(1)(iii), 1271.75(a)(1), 1271.85(b)(2), 1271.55(b)(4), 1271.60(a), 1271.65(b), 1271.65(b)(2) and 4 more |
| Inspection city | Boca Raton |
| Inspection ZIP | 33433 |
| Inspection start date | May 31, 2022 |
| 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: