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 3010331770.
Observations3
Issue DateFebruary 09, 2026
StatusNo Warning Letter
Establishment TypeManufacturer
Related Inspections3
Establishment Details
Firm
BioSensics LLC
Location
Newton, Massachusetts
FEI Number
3010331770
Establishment Type
Manufacturer
Product Type
Devices
Issue Date
February 09, 2026
Country
United States
Inspection History, 2018 to 2026
NAI1
VAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
Talk to a Specialist