FDA Inspection
Shin Chang Medical Co., Ltd.Shin Chang Medical Co., Ltd. – FDA Inspection, Nov 17, 2022
Record Details
This FDA Inspection record concerns Shin Chang Medical Co., Ltd., with an inspection on November 17, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Shin Chang Medical Co., Ltd.
- Inspection Date
- November 17, 2022
- Product Type
- Devices
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ID · ebaa97b1-17ce-476e-9c34-ba4ff155582c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1191697
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.184DHR content
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Other FDA inspections of Shin Chang Medical Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 5, 2024 | VAI | Office of Inspections and Investigations | Compliance: Medical Devices |
| April 26, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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