Warning letter
Pikeville Medical Center Inc., Institutional Review Board: warning letter of Mar 1, 2016
FDA warning letter 484248 · Center for Drug Evaluation and Research
Key facts
| Reference number | 484248 |
|---|---|
| Company | Pikeville Medical Center Inc., Institutional Review Board |
| Subject | Institutional Review Board (IRB) |
| Issue date | Mar 1, 2016 |
| Posted date | Apr 12, 2016 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 56.115(a)(6), 56.108(a)(1), 56.108(a)(2), 56.108(b)(1), 56.108(b)(2), 56.107(a), 56.107(e), 56.108(a), 56.115(a)(2), 56.115(a)(5), 56.108(c), 56.108(b) and 2 more |
| Inspection city | Pikeville |
| Inspection ZIP | 41501 |
| Inspection start date | Aug 17, 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: