BioSensics LLC

FDA inspection history in Newton, Massachusetts, 2026

1
Form 483

Every document, by year

  • Form 483

2026: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2026One Form 483, at Newton, Massachusetts.

Cited most

Across all BioSensics observations on file

  • ISO 13485:2016 Clause 7.3.1
    Definitions
    1
  • ISO 13485:2016 Clause 8.3.1
    1
  • ISO 13485:2016 Clause 8.5.2
    1

The complete BioSensics file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2026-02-09483 Form 483$99

Investigators on these documents

James P. Finn (1)

FEI number 3010331770 · most recent document Feb 9, 2026

About BioSensics LLC

How many FDA Form 483s has BioSensics LLC received?

FDA Intel has 1 Form 483 on file for BioSensics LLC; the most recent is dated Feb 9, 2026.

When was BioSensics LLC last inspected by FDA?

The most recent FDA inspection document on file for BioSensics LLC is a Form 483 dated Feb 9, 2026, for the site in Newton, Massachusetts.

What did FDA cite at BioSensics LLC?

The regulations cited most in the observations on file for BioSensics LLC are ISO 13485:2016 Clause 7.3.1 (Definitions), 1 time; ISO 13485:2016 Clause 8.3.1, 1 time; ISO 13485:2016 Clause 8.5.2, 1 time.