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 3004153240.
Observations1
Issue DateJanuary 13, 2026
Status1 Related Warning Letter
Related Inspections4
Establishment Details
Firm
Conformis Inc.
Location
Wilmington, Massachusetts
FEI Number
3004153240
Product Type
Devices
Issue Date
January 13, 2026
Country
United States
Inspection History, 2015 to 2026
NAI1
VAI2
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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