FDA Inspection
Anaxdent North America LLCAnaxdent North America LLC – FDA Inspection, Nov 19, 2015
Record Details
This FDA Inspection record concerns Anaxdent North America LLC, with an inspection on November 19, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Anaxdent North America LLC
- Inspection Date
- November 19, 2015
- Product Type
- Devices
View Company Profile
ID · de808785-84dc-46d4-a39d-1241b63ee17e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 949302
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.