FDA Inspection
Richway & Fuji Bio Inc.Richway & Fuji Bio Inc. – FDA Inspection, Jun 13, 2014
Record Details
This FDA Inspection record concerns Richway & Fuji Bio Inc., with an inspection on June 13, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Richway & Fuji Bio Inc.
- Inspection Date
- June 13, 2014
- Product Type
- Devices
View Company Profile
ID · 39d43297-e6c8-4f57-9e44-e110e358010f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 883924
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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Other FDA inspections of Richway & Fuji Bio Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2018 | Not classified | San Francisco District Office | |
| February 16, 2017 | Not classified | San Francisco District Office |
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