Warning letter
Essex Institutional Review Board, Inc [ARCHIVED]: warning letter of Jul 26, 2011
FDA warning letter 192392 · Center for Drug Evaluation and Research
Key facts
| Reference number | 192392 |
|---|---|
| Company | Essex Institutional Review Board, Inc [ARCHIVED] |
| Subject | Institutional Review Board (IRB) |
| Issue date | Jul 26, 2011 |
| Posted date | Jul 26, 2011 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 50.25, 50.50, 50.51, 56.107, 56.110, 50, 50.25(a)(2), 56.102(i), 56.107(a), 56.111(a)(1), 56.109(b), 56.109(h) and 1 more |
| Inspection city | Lebanon |
| Inspection ZIP | 08833 |
| Inspection start date | Mar 14, 2011 |
| 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: