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Warning Letter

Case 647320 — FEI 1037230

Facility

Recent inspections

  • 1254427 (OAI Tue Nov 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1179116 (NAI Thu Sep 08 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 866457 (NAI Wed Feb 19 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Sea-Long Medical Systems, LLC
Date
April 4, 2023
Fiscal Year
2023
Product Type
Devices
Center
CDRH
Location
Waxahachie, TX (United States)