Warning letter
Advantage Medical Electronics: warning letter of Oct 31, 2003
FDA warning letter UCM147808 · Florida District Office
Key facts
| Reference number | UCM147808 |
|---|---|
| Company | Advantage Medical Electronics |
| Subject | Quality System Regulation/Medical Device Reporting Regulation/Misbranded/Adulerated |
| Issue date | Oct 31, 2003 |
| Posted date | Oct 31, 2003 |
| Issuing office | Florida District Office |
| Product type | Devices |
| CFR sections cited | 820, 803, 803.17 |
| Country | 3 |
| Inspection city | Coral Springs |
| Inspection ZIP | 33065-2511 |
| Inspection start date | Aug 26, 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: