FDA Inspection
The Yoshida Dental Manufacturing Co., Ltd.The Yoshida Dental Manufacturing Co., Ltd. – FDA Inspection, Mar 31, 2017
Record Details
This FDA Inspection record concerns The Yoshida Dental Manufacturing Co., Ltd., with an inspection on March 31, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- March 31, 2017
- Product Type
- Medical Devices & Rad Health
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ID · ec022c13-eacc-4c88-bd18-304cafd98735
Inspection Facts
- Inspection number
- 1010237
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 1002.13Lack of required elements
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of The Yoshida Dental Manufacturing Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 4, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 14, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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