Warning letter
Larkin Community Hospital Institutional Review Board: warning letter of Jan 11, 2023
FDA warning letter 638146 · Center for Drug Evaluation and Research | CDER
Key facts
| Reference number | 638146 |
|---|---|
| Company | Larkin Community Hospital Institutional Review Board |
| Subject | Bioresearch Monitoring Program/Institutional Review Board (IRB) |
| Issue date | Jan 11, 2023 |
| Posted date | Jan 24, 2023 |
| Issuing office | Center for Drug Evaluation and Research | CDER |
| Product type | Drugs |
| CFR sections cited | 50.25(c), 56.115(a)(5), 56.108(c), 56.115(a), 56.109(b), 11.10, 50.25 |
| Inspection city | South Miami |
| Inspection ZIP | 33143 |
| Inspection start date | Nov 12, 2021 |
| 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: