FDA Inspection
Shirakawa Olympus Co., Ltd.Shirakawa Olympus Co., Ltd. – FDA Inspection, Mar 15, 2012
Record Details
This FDA Inspection record concerns Shirakawa Olympus Co., Ltd., with an inspection on March 15, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Shirakawa Olympus Co., Ltd.
- Inspection Date
- March 15, 2012
- Product Type
- Devices
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ID · 5af2fc75-63e9-47f3-8b3e-bccf9ce9d5b3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 776531
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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Other FDA inspections of Shirakawa Olympus Co., Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2025 | Not classified | Office of Inspections and Investigations | Compliance: Medical Devices |
| November 17, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 13, 2018 | Not classified | Office of Inspections and Investigations | |
| May 21, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Shirakawa Olympus Co., Ltd.
- FDA Inspection 1291254 - 2025-11-14
- FDA Inspection 1192279 - 2022-11-17
- FDA Inspection 1068507 - 2018-09-13
- FDA Inspection 928917 - 2015-05-21
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