Warning letter
Olympus Medical Systems Corporation: warning letter of Dec 12, 2022
FDA warning letter 649726 · Center for Devices and Radiological Health
Key facts
| Reference number | 649726 |
|---|---|
| Company | Olympus Medical Systems Corporation |
| Subject | Medical Device Reporting/Misbranded |
| Issue date | Dec 12, 2022 |
| Posted date | Jan 10, 2023 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.50(a)(2) |
| Inspection city | Hachioji |
| Inspection start date | Sep 6, 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: