FDA Inspection
American Dental Partners, Inc.American Dental Partners, Inc. – FDA Inspection, Jan 30, 2013
Record Details
This FDA Inspection record concerns American Dental Partners, Inc., with an inspection on January 30, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 30, 2013
- Product Type
- Devices
View Company Profile
ID · 3e14ae24-8246-4d1d-af96-14db812914a6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 816414
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 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.