FDA Inspection
Amvex CorporationAmvex Corporation – FDA Inspection, Jun 18, 2015
Record Details
This FDA Inspection record concerns Amvex Corporation, with an inspection on June 18, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Amvex Corporation
- Inspection Date
- June 18, 2015
- Product Type
- Devices
View Company Profile
ID · 409504d5-abbf-4e5f-8bd0-b31d2c57cb98
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 935001
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.140Lack of or inadequate procedures for handling
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