FDA Inspection
Mectron SPAMectron SPA – FDA Inspection, Dec 1, 2011
Record Details
This FDA Inspection record concerns Mectron SPA, with an inspection on December 1, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mectron SPA
- Inspection Date
- December 1, 2011
- Product Type
- Devices
View Company Profile
ID · 6220546b-943b-4151-9460-1db1ea0a81b8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 760439
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.200(d)Service reports
- 21 CFR 803.40(b)Report of malfunction likely to cause death or injury
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.