Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3002743211.
Observations4
Issue DateAugust 28, 2025
StatusNo Warning Letter
Establishment TypeMedical Device Manufacturer
Related Inspections4
Establishment Details
Firm
Northern Digital Inc.
Location
Waterloo
FEI Number
3002743211
Establishment Type
Medical Device Manufacturer
Product Type
Devices
Issue Date
August 28, 2025
Country
N/A
Inspection History, 2013 to 2025
NAI1
VAI1
OAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.