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Warning Letter
Case 709948 — FEI 3019216
Facility
Facility 3019216
Recent inspections
1253946
(OAI Fri Jan 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
1157069
(NAI Wed Nov 10 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
761739
(VAI Fri Dec 09 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
Action Details
Facility
Philips Ultrasound, LLC
Date
September 9, 2025
Fiscal Year
2025
Product Type
Devices
Center
CDRH
Location
Bothell, WA (United States)