Warning letter
Encore, Inc.: warning letter of Mar 24, 2004
FDA warning letter UCM146285 · Florida District Office
Key facts
| Reference number | UCM146285 |
|---|---|
| Company | Encore, Inc. |
| Subject | QSR/Lacks Premarket Approval Application/Adulterated/Misbranded |
| Issue date | Mar 24, 2004 |
| Posted date | Mar 24, 2004 |
| Issuing office | Florida District Office |
| Product type | Devices |
| CFR sections cited | 803.17, 801.4, 803, 807.39, 807.81, 820, 807.35(c) |
| Country | 3 |
| Inspection city | Sarasota |
| Inspection ZIP | 34243-4091 |
| Inspection start date | Nov 4, 2003 |
| 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: