Warning letter
Konrad Rejdak, M.D., Ph.D.: warning letter of May 29, 2024
FDA warning letter 671405 · Center for Biologics Evaluation and Research (CBER)
Key facts
| Reference number | 671405 |
|---|---|
| Company | Konrad Rejdak, M.D., Ph.D. |
| Subject | Bioresearch Monitoring Program/IRB |
| Issue date | May 29, 2024 |
| Posted date | Aug 13, 2024 |
| Issuing office | Center for Biologics Evaluation and Research (CBER) |
| Product type | Biologics |
| CFR sections cited | 312, 312.60, 312.62(b), 312.62(c) |
| Inspection city | Lublin |
| Inspection start date | May 15, 2023 |
| 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: