Warning letter
Draegar Medical Systems, Inc.: warning letter of Jan 17, 2020
FDA warning letter 596529 · Office of Medical Device and Radiological Health Operations (Division 1)
Key facts
| Reference number | 596529 |
|---|---|
| Company | Draegar Medical Systems, Inc. |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Issue date | Jan 17, 2020 |
| Posted date | Jan 28, 2020 |
| Issuing office | Office of Medical Device and Radiological Health Operations (Division 1) |
| Product type | Devices |
| CFR sections cited | 820, 807.81(b) |
| Inspection city | Andover |
| Inspection ZIP | 01810 |
| Inspection start date | Aug 20, 2019 |
| 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: