Warning letter
Medical Device Resource Corp: warning letter of Sep 20, 2013
FDA warning letter 397781 · San Francisco District Office
Key facts
| Reference number | 397781 |
|---|---|
| Company | Medical Device Resource Corp |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Sep 20, 2013 |
| Posted date | Sep 20, 2013 |
| Issuing office | San Francisco District Office |
| Product type | Devices |
| CFR sections cited | 820.40, 803, 803.3, 803.17, 820, 803.50(b) |
| Inspection city | Livermore |
| Inspection ZIP | 94550 |
| Inspection start date | Mar 5, 2013 |
| 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: