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Warning Letter

Case 655666 — FEI 1626310

Facility

Recent inspections

  • 1197186 (OAI Fri Feb 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1118892 (NAI Fri Feb 07 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1065390 (NAI Wed Aug 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1039153 (VAI Wed Jan 31 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 934315 (OAI Fri Jul 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Other compliance actions

Action Details

Facility
Iso-Tex Diagnostics, Inc.
Date
July 20, 2023
Fiscal Year
2023
Product Type
Drugs
Center
CDER
Location
Alvin, TX (United States)