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 3003224146.
Observations4
Issue DateMarch 10, 2023
StatusNo Warning Letter
Related Inspections5
Establishment Details
Firm
Enterix, Inc.
Location
Edison, New Jersey, United States
FEI Number
3003224146
Product Type
Devices
Issue Date
March 10, 2023
Country
United States
Inspection History, 2010 to 2026
NAI2
VAI3
NAI means No Action Indicated. VAI means Voluntary Action Indicated.