Polygon Medical, Inc
Form 483 issued April 25, 2024 · Holliston, Massachusetts
- Inspection
- Apr 23 – Apr 25, 2024
- Investigator
- James P. Finn
- Observations
- 3
- Pages
- 4
- FEI number
- 3014407293
In short: On April 25, 2024, FDA issued a Form 483 with 3 observations to Polygon Medical, Inc in Holliston, Massachusetts (FEI 3014407293) after an inspection that ran Apr 23 – Apr 25, 2024. The investigator was James P. Finn. Most observations concern cAPA and management controls.
At a glance
2 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for collective and preventive action have…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 03
Procedures for quality audits have…
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 firmPolygon Medical, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Polygon Medical, Inc?
FDA listed 3 observations on this Form 483, mostly about cAPA and management controls. The opening words of each observation are shown on this page.
Who inspected Polygon Medical, Inc?
James P. Finn is named on this Form 483, for the inspection of Apr 23 – Apr 25, 2024. Each investigator has a profile showing what they cite most.
When was Polygon Medical, Inc inspected by FDA?
The inspection ran Apr 23 – Apr 25, 2024, and the Form 483 is dated April 25, 2024.
How do I get the full Form 483 for Polygon Medical, Inc?
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.