Warning letter
Advocate Health Care: warning letter of Jun 1, 2012
FDA warning letter 289899 · Center for Drug Evaluation and Research
Key facts
| Reference number | 289899 |
|---|---|
| Company | Advocate Health Care |
| Subject | Institutional Review Board (IRB) |
| Issue date | Jun 1, 2012 |
| Posted date | Jun 1, 2012 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 56, 56.111(a)(4), 56.111, 50.24, 50 |
| Inspection city | Downers Grove |
| Inspection ZIP | 60515 |
| Inspection start date | Nov 7, 2011 |
| Letter on fda.gov | web.archive.org |
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: