FDA Inspection
Wonjin Mulsan Co., Ltd.Wonjin Mulsan Co., Ltd. – FDA Inspection, Apr 4, 2013
Record Details
This FDA Inspection record concerns Wonjin Mulsan Co., Ltd., with an inspection on April 4, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Wonjin Mulsan Co., Ltd.
- Inspection Date
- April 4, 2013
- Product Type
- Devices
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ID · be32fc73-6f64-482d-bbc7-630a4c51c257
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 828626
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Wonjin Mulsan Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 22, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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