Warning letter
Case Western Reserve University: warning letter of Apr 16, 2004
FDA warning letter UCM146838 · Center for Devices and Radiological Health
Key facts
| Reference number | UCM146838 |
|---|---|
| Company | Case Western Reserve University |
| Subject | Good Laboratory Practices |
| Issue date | Apr 16, 2004 |
| Posted date | Apr 16, 2004 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 58.31, 58.33, 58.35, 58.63, 58.190 |
| Country | 3 |
| Inspection city | Cleveland |
| Inspection ZIP | 44106-1712 |
| Inspection start date | Oct 30, 2003 |
| 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: