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 3011578544.
Observations7
Issue DateMarch 05, 2026
StatusNo Warning Letter
Related Inspections2
Establishment Details
Firm
Gentuity, LLC
Location
Sudbury, Massachusetts
FEI Number
3011578544
Product Type
Devices
Issue Date
March 05, 2026
Country
United States
Inspection History, 2022 to 2026
NAI1
OAI1
NAI means No Action Indicated. OAI means Official Action Indicated.