FDA Inspection
DMP Dental Industry S.A.DMP Dental Industry S.A. – FDA Inspection, Oct 8, 2015
Record Details
This FDA Inspection record concerns DMP Dental Industry S.A., with an inspection on October 8, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DMP Dental Industry S.A.
- Inspection Date
- October 8, 2015
- Product Type
- Devices
View Company Profile
ID · 7df6dc8a-9881-475f-b4d0-62f09a9356b4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 947476
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
12- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.250(a)Statistical techniques - 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
Showing 10 of 12 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of DMP Dental Industry S.A.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 13, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for DMP Dental Industry S.A.
- FDA Inspection 1030086 - 2017-07-13
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.