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 3007138831.
Observations2
Issue DateOctober 24, 2025
StatusNo Warning Letter
Related Inspections4
Establishment Details
Firm
Allwell Medical Corporation
Location
Raleigh, North Carolina, United States
FEI Number
3007138831
Product Type
Devices
Issue Date
October 24, 2025
Country
United States
Inspection History, 2011 to 2025
NAI1
VAI3
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
Talk to a Specialist