FDA Inspection
Genway Biotech Inc.Genway Biotech Inc. – FDA Inspection, Jun 14, 2018
Record Details
This FDA Inspection record concerns Genway Biotech Inc., with an inspection on June 14, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 85cd4296-a9a6-400c-bb7e-c787d1ee5b27
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1056861
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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