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Compliance actions
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Warning Letter
Case 656485 — FEI 3010355846
Facility
Facility 3010355846
Recent inspections
1251442
(VAI Wed Sep 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
1196985
(OAI Fri Feb 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
Action Details
Facility
Outset Medical, Inc.
Date
July 5, 2023
Fiscal Year
2023
Product Type
Devices
Center
CDRH
Location
San Jose, CA (United States)