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 3018739912.
Observations2
Issue DateApril 11, 2025
StatusNo Warning Letter
Related Inspections2
Establishment Details
Firm
Renalytix AI, Inc.
Location
New York, New York, United States
FEI Number
3018739912
Product Type
Devices
Issue Date
April 11, 2025
Country
United States
Inspection History, 2022 to 2025
NAI1
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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