FDA Inspection
EZGO GROUP INCEZGO GROUP INC – FDA Inspection, Dec 22, 2021
Record Details
This FDA Inspection record concerns EZGO GROUP INC, with an inspection on December 22, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- EZGO GROUP INC
- Inspection Date
- December 22, 2021
- Product Type
- Devices
View Company Profile
ID · 80208a48-a177-47a0-a747-d3d329fa4222
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1159490
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 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 803.17Lack of Written MDR Procedures
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