Warning letter
Electro Medical, Inc.: warning letter of Sep 7, 2005
FDA warning letter UCM075551 · Dallas District Office
Key facts
| Reference number | UCM075551 |
|---|---|
| Company | Electro Medical, Inc. |
| Subject | Current Good Manufacturing Practice/Adulterated |
| Issue date | Sep 7, 2005 |
| Posted date | Sep 7, 2005 |
| Issuing office | Dallas District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.17, 820, 820.40 |
| Country | 3 |
| Inspection city | Tulsa |
| Inspection ZIP | 74137-6242 |
| Inspection start date | Jun 28, 2005 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- 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: