Warning letter
Medical Device Resource Corporation: warning letter of Dec 21, 2007
FDA warning letter UCM076605 · San Francisco District Office
Key facts
| Reference number | UCM076605 |
|---|---|
| Company | Medical Device Resource Corporation |
| Subject | Premarket Approval/Misbranded/Adulterated |
| Issue date | Dec 21, 2007 |
| Posted date | Dec 21, 2007 |
| Issuing office | San Francisco District Office |
| Product type | Devices |
| CFR sections cited | 878.4780, 807.81(a), 807.81(b) |
| Country | 3 |
| Inspection city | Livermore |
| Inspection ZIP | 94550-9710 |
| Inspection start date | Aug 15, 2007 |
| 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: