Warning letter
Zyno Medical LLC: warning letter of Jul 12, 2022
FDA warning letter 629844 · Office of Medical Devices and Radiological Health Operations Div. 1 East
Key facts
| Reference number | 629844 |
|---|---|
| Company | Zyno Medical LLC |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jul 12, 2022 |
| Posted date | Aug 9, 2022 |
| Issuing office | Office of Medical Devices and Radiological Health Operations Div. 1 East |
| Product type | Devices |
| CFR sections cited | 803, 803.50(a)(2), 820, 807.81(b) |
| Inspection city | Natick |
| Inspection ZIP | 01760 |
| Inspection start date | Jan 19, 2022 |
| 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: