FDA Inspection
Prince Medical S.A.S.Prince Medical S.A.S. – FDA Inspection, Mar 28, 2012
Record Details
This FDA Inspection record concerns Prince Medical S.A.S., with an inspection on March 28, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Prince Medical S.A.S.
- Inspection Date
- March 28, 2012
- Product Type
- Devices
View Company Profile
ID · 74a193b7-7a46-4e3c-ac7e-e4c0c04224f0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 773859
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint 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.