Warning letter
Enneking Medical Inc.: warning letter of Sep 17, 2004
FDA warning letter UCM146603 · Kansas City District Office
Key facts
| Reference number | UCM146603 |
|---|---|
| Company | Enneking Medical Inc. |
| Subject | GMP for Medical Devices/QSR/Adulterated |
| Issue date | Sep 17, 2004 |
| Posted date | Sep 17, 2004 |
| Issuing office | Kansas City District Office |
| Product type | Devices |
| CFR sections cited | 803.17, 880.2720, 880.5500, 880.5510, 820, 890.5100 |
| Country | 3 |
| Inspection city | Kansas City |
| Inspection ZIP | 66111-1605 |
| Inspection start date | Jul 27, 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: