FDA Inspection
AudigenceAudigence – FDA Inspection, Mar 30, 2011
Record Details
This FDA Inspection record concerns Audigence, with an inspection on March 30, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Audigence
- Inspection Date
- March 30, 2011
- Product Type
- Devices
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ID · 53e1eb06-dbb2-4e44-8a0e-07001dedb2ea
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 717167
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 803.17Lack of Written MDR Procedures
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