Warning letter
Monmouth Medical Center IRB: warning letter of Nov 10, 2015
FDA warning letter 480052 · Center for Drug Evaluation and Research
Key facts
| Reference number | 480052 |
|---|---|
| Company | Monmouth Medical Center IRB |
| Subject | Institutional Review Board (IRB) |
| Issue date | Nov 10, 2015 |
| Posted date | Feb 2, 2016 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 50.50, 50.51, 50.52, 50.53, 56.115, 50, 56.107(a), 56.107(e), 56.115(a)(2), 56.108(c), 56.109(h) |
| Inspection city | Long Branch |
| Inspection ZIP | 07740 |
| Inspection start date | Apr 1, 2015 |
| Letter on fda.gov | web.archive.org |
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: