FDA Inspection
Sakura Seiki Co., Ltd. Chikuma FactorySakura Seiki Co., Ltd. Chikuma Factory – FDA Inspection, Mar 24, 2023
Record Details
This FDA Inspection record concerns Sakura Seiki Co., Ltd. Chikuma Factory, with an inspection on March 24, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · aff846ed-48ee-47c2-9e32-e93e66855031
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1200617
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
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Other FDA inspections of Sakura Seiki Co., Ltd. Chikuma Factory
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 5, 2026 | Not classified | Office of Inspections and Investigations | |
| February 15, 2019 | Not classified | Office of Inspections and Investigations |
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