Home / Compliance actions / 576934

Warning Letter

Case 576934 — FEI 3002698769

Facility

Recent inspections

  • 1197996 (NAI Mon Jan 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1150957 (VAI Tue Sep 07 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1080894 (OAI Fri Feb 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 889994 (NAI Thu Aug 07 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 791491 (VAI Fri Jul 20 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
Date
July 31, 2019
Fiscal Year
2019
Product Type
Devices
Center
CDRH
Location
Whitestown, IN (United States)