Warning letter
Klarity Medical Products LLC: warning letter of Jun 8, 2020
FDA warning letter 606982 · Division of Medical Device and Radiological Health Operations East
Key facts
| Reference number | 606982 |
|---|---|
| Company | Klarity Medical Products LLC |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Issue date | Jun 8, 2020 |
| Posted date | Jun 16, 2020 |
| Issuing office | Division of Medical Device and Radiological Health Operations East |
| Product type | Devices |
| CFR sections cited | 806, 820, 806.10(a), 806.10(b), 807.81(b), 892.5050 |
| Inspection city | Heath |
| Inspection ZIP | 43056 |
| Inspection start date | Feb 10, 2020 |
| 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: