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 3003945344.
Observations3
Issue DateJanuary 27, 2025
Status1 Related Warning Letter
Related Inspections4
Establishment Details
Firm
Insightra Medical Inc
Location
Clarksville, Tennessee, United States
FEI Number
3003945344
Product Type
Devices
Issue Date
January 27, 2025
Country
United States
Inspection History, 2010 to 2025
VAI2
OAI2
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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