Warning letter
I.V. Flush, LLC: warning letter of Aug 4, 2005
FDA warning letter UCM075511 · Dallas District Office
Key facts
| Reference number | UCM075511 |
|---|---|
| Company | I.V. Flush, LLC |
| Subject | Current Good Manufacturing Practices Requirements for Medical Devices/Adulterated |
| Issue date | Aug 4, 2005 |
| Posted date | Aug 4, 2005 |
| Issuing office | Dallas District Office |
| Product type | Devices |
| CFR sections cited | 803.50(a), 803.17, 820, 820.40 |
| Country | 3 |
| Inspection city | Rowlett |
| Inspection ZIP | 75088-4033 |
| Inspection start date | Jan 28, 2005 |
| 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: