Warning letter
DeChoker LLC: warning letter of May 10, 2021
FDA warning letter 614629 · Office of Medical Device and Radiological Health, Division 3
Key facts
| Reference number | 614629 |
|---|---|
| Company | DeChoker LLC |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | May 10, 2021 |
| Posted date | Jun 1, 2021 |
| Issuing office | Office of Medical Device and Radiological Health, Division 3 |
| Product type | Devices |
| CFR sections cited | 820, 868.6810 |
| Inspection city | Wheat Ridge |
| Inspection ZIP | 80033 |
| Inspection start date | Feb 17, 2021 |
| Letter on fda.gov | fda.gov |
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: