FDA Inspection
Shin Chang Medical Co., Ltd.Shin Chang Medical Co., Ltd. – FDA Inspection, Dec 5, 2024
Record Details
This FDA Inspection record concerns Shin Chang Medical Co., Ltd., with an inspection on December 5, 2024, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Shin Chang Medical Co., Ltd.
- Inspection Date
- December 5, 2024
- Product Type
- Medical Devices & Rad Health
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ID · ea88b3d6-0202-4d59-813b-68812aa1ce3f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1256912
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Shin Chang Medical Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 26, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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