Warning letter
Synovo Production, Inc.: warning letter of Mar 23, 2023
FDA warning letter 647427 · Division of Medical Device and Radiological Health Operations West
Key facts
| Reference number | 647427 |
|---|---|
| Company | Synovo Production, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Mar 23, 2023 |
| Posted date | Apr 4, 2023 |
| Issuing office | Division of Medical Device and Radiological Health Operations West |
| Product type | Devices |
| CFR sections cited | 888.3410, 807.81(b), 812, 807.81(a)(3), 820 |
| Inspection city | Fullerton |
| Inspection ZIP | 92835 |
| Inspection start date | Oct 11, 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: