FDA Inspection 1179320 — Olympus Medical Systems Corporation
The FDA completed an inspection of Olympus Medical Systems Corporation on Sep 9, 2022 in Hachioji. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 9, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hachioji (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |