Warning letter
Medical Device Consulting: warning letter of Sep 3, 2003
FDA warning letter UCM147691 · Center for Devices and Radiological Health
Key facts
| Reference number | UCM147691 |
|---|---|
| Company | Medical Device Consulting |
| Subject | Sponsor Obligations |
| Issue date | Sep 3, 2003 |
| Posted date | Sep 3, 2003 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 812.25, 812.40, 812.42, 812.46, 812.140, 812.150 |
| Country | 3 |
| Inspection city | Centerville |
| Inspection ZIP | 02632-2402 |
| Inspection start date | Apr 23, 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: