BioSensics LLC
Form 483 issued February 9, 2026 · Newton, Massachusetts
- Inspection
- Feb 3 – Feb 9, 2026
- Investigator
- James P. Finn
- Observations
- 3
- Pages
- 5
- FEI number
- 3010331770
In short: On February 9, 2026, FDA issued a Form 483 with 3 observations to BioSensics LLC in Newton, Massachusetts (FEI 3010331770) after an inspection that ran Feb 3 – Feb 9, 2026. The investigator was James P. Finn.
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 7.3.1
Design and development procedures…
- 02ISO 13485:2016 Clause 8.5.2
Corrective action was not adequately taken to eliminate the cause of nonconformities in…
- 03ISO 13485:2016 Clause 8.3.1
Product which does not conform to product requirements was not adequately identified and controlled to prevent…
This inspection in context
James P. Finn
10 documents · 2019–2026
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Massachusetts.
The firmBioSensics LLC history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at BioSensics LLC?
FDA listed 3 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected BioSensics LLC?
James P. Finn is named on this Form 483, for the inspection of Feb 3 – Feb 9, 2026. Each investigator has a profile showing what they cite most.
When was BioSensics LLC inspected by FDA?
The inspection ran Feb 3 – Feb 9, 2026, and the Form 483 is dated February 9, 2026.
How do I get the full Form 483 for BioSensics LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.