Warning letter
Encompass Group, LLC [ARCHIVED]: warning letter of Jun 2, 2010
FDA warning letter 99425 · Atlanta District Office
Key facts
| Reference number | 99425 |
|---|---|
| Company | Encompass Group, LLC [ARCHIVED] |
| Subject | Medical Device Reporting (MDR) Regulation Misbranded |
| Issue date | Jun 2, 2010 |
| Posted date | Jun 2, 2010 |
| Issuing office | Atlanta District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.17, 820 |
| Inspection city | Mcdonough |
| Inspection ZIP | 30253 |
| Inspection start date | Dec 15, 2009 |
| 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: