Warning letter
Olympus Medical Systems Corp.: warning letter of Mar 15, 2023
FDA warning letter 654013 · Center for Devices and Radiological Health
Key facts
| Reference number | 654013 |
|---|---|
| Company | Olympus Medical Systems Corp. |
| Subject | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Issue date | Mar 15, 2023 |
| Posted date | Mar 17, 2023 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.12(a), 803.17(a), 803.17(a)(1), 803.17(a)(2), 803.17(a)(3), 803.50(a)(2), 820, 803.50(a) |
| Inspection city | Nishitama-Gun |
| Inspection start date | Nov 7, 2022 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 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: