Warning letter
DANA Diabecare USA LLC: warning letter of Jul 23, 2004
FDA warning letter UCM146522 · New Orleans District Office
Key facts
| Reference number | UCM146522 |
|---|---|
| Company | DANA Diabecare USA LLC |
| Subject | Medical Device Reporting/Misbranded |
| Issue date | Jul 23, 2004 |
| Posted date | Jul 23, 2004 |
| Issuing office | New Orleans District Office |
| Product type | Devices |
| CFR sections cited | 20.64(d)(3), 803, 803.17, 803.40, 803.42, 803.17(b)(2), 803.17(b)(4), 803.3(bb), 803.40(a) |
| Country | 3 |
| Inspection city | New Orleans |
| Inspection ZIP | 70130-3690 |
| Inspection start date | Feb 19, 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: