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Warning Letter
Case 634208 — FEI 3003071743
Facility
Facility 3003071743
Recent inspections
1275275
(OAI Thu Jun 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
1169174
(OAI Thu Apr 28 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
1100810
(NAI Thu Aug 29 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
898560
(VAI Thu Oct 02 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
713618
(VAI Fri Mar 04 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
Action Details
Facility
JAS Diagnostics, Inc./Drew Scientific, Inc.
Date
August 16, 2022
Fiscal Year
2022
Product Type
Devices
Center
CDRH
Location
Miami Lakes, FL (United States)