Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3010355846.
Observations4
Issue DateFebruary 10, 2023
Status1 Related Warning Letter
Related Inspections2
Establishment Details
Firm
Outset Medical, Inc.
Location
San Jose, California, United States
FEI Number
3010355846
Product Type
Devices
Issue Date
February 10, 2023
Country
United States
Inspection History, 2023 to 2024
VAI1
OAI1
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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