Warning letter
Applied Water Engineering, Inc.: warning letter of Dec 27, 2006
FDA warning letter UCM076224 · Denver District Office
Key facts
| Reference number | UCM076224 |
|---|---|
| Company | Applied Water Engineering, Inc. |
| Subject | CGMP/QSR/Medical Device Reporting/Adulterated |
| Issue date | Dec 27, 2006 |
| Posted date | Dec 27, 2006 |
| Issuing office | Denver District Office |
| Product type | Devices |
| CFR sections cited | 803.50(b)(3), 803, 803.3, 803.17, 803.22, 803.50, 803.52, 803.53, 803.56, 803.18, 820, 807.81(b) |
| Country | 3 |
| Inspection city | Salt Lake City |
| Inspection ZIP | 84115-2953 |
| Inspection start date | Jul 11, 2006 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: