Home / Compliance actions / 131290

Warning Letter

Case 131290 — FEI 3004022340

Facility

Recent inspections

  • 941431 (OAI Thu Aug 13 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 921358 (OAI Fri Apr 03 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 847869 (OAI Fri Sep 13 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 665333 (OAI Thu May 27 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Other compliance actions

  • Injunction (249) (Tue Oct 06 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
2035 PMA
Date
March 2, 2011
Fiscal Year
2011
Product Type
Devices
Center
CDRH
Location
Rapid City, SD (United States)