FDA Inspection
Exacta Dental Products, Inc.Exacta Dental Products, Inc. – FDA Inspection, Mar 22, 2016
Record Details
This FDA Inspection record concerns Exacta Dental Products, Inc., with an inspection on March 22, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Exacta Dental Products, Inc.
- Inspection Date
- March 22, 2016
- Product Type
- Devices
View Company Profile
ID · 548e9b38-54b2-4e6b-bbee-d9ded9f3e1ba
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 971851
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately 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 audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, 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.