FDA Inspection
Kyungwon Medical Co., Ltd.Kyungwon Medical Co., Ltd. – FDA Inspection, Sep 20, 2012
Record Details
This FDA Inspection record concerns Kyungwon Medical Co., Ltd., with an inspection on September 20, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kyungwon Medical Co., Ltd.
- Inspection Date
- September 20, 2012
- Product Type
- Devices
View Company Profile
ID · e637ad7a-cca6-46fe-8234-d04a92dff2cd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 800237
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
- 21 CFR 820.30(g)Design validation - production units
- 21 CFR 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
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