FDA Inspection
Kawada Sanitary Products Co., Ltd.Kawada Sanitary Products Co., Ltd. – FDA Inspection, Jul 31, 2014
Record Details
This FDA Inspection record concerns Kawada Sanitary Products Co., Ltd., with an inspection on July 31, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 31, 2014
- Product Type
- Devices
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ID · a2f36eac-1d3e-4b92-bc3a-5ac4ae0cace1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 890036
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.80(e)Documentation
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.30(h)Design transfer - 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
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 803.17Lack of Written MDR Procedures
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