Warning letter
General Medical Company: warning letter of Sep 8, 2004
FDA warning letter UCM146585 · Los Angeles District Office
Key facts
| Reference number | UCM146585 |
|---|---|
| Company | General Medical Company |
| Subject | QSR for Medical Devices/Medical Device Reporting/Misbranded/Adulterated |
| Issue date | Sep 8, 2004 |
| Posted date | Sep 8, 2004 |
| Issuing office | Los Angeles District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.17(a)(2), 820, 820.5 |
| Country | 3 |
| Inspection city | Ponte Vedra Beach |
| Inspection ZIP | 32082-8209 |
| Inspection start date | Jul 20, 2004 |
| 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: