Agile Devices, Inc
Form 483 issued February 20, 2026 · Newton Center, Massachusetts
- Inspection
- Feb 17 – Feb 20, 2026
- Investigator
- James P. Finn
- Observations
- 5
- Pages
- 8
- FEI number
- 3023167283
In short: On February 20, 2026, FDA issued a Form 483 with 5 observations to Agile Devices, Inc in Newton Center, Massachusetts (FEI 3023167283) after an inspection that ran Feb 17 – Feb 20, 2026. The investigator was James P. Finn. The most-cited regulation is 21 CFR 8.2.
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 7.3.9
Procedures to control design and development changes…
- 02ISO 13485:2016 Clause 8.2.2
Procedures for timely complaint handling have…
- 03ISO 13485:2016 Clause 8.5.2
Corrective action procedures defining the requirements for evaluating the need for action to ensure that nonconformities…
- 04ISO 13485:2016 Clause 4.1.5
Outsourced processes that affect product conformity to requirements were not…
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 firmAgile Devices, Inc history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Agile Devices, Inc?
FDA listed 5 observations on this Form 483. The most-cited regulation is 21 CFR 8.2. The opening words of each observation are shown on this page.
Who inspected Agile Devices, Inc?
James P. Finn is named on this Form 483, for the inspection of Feb 17 – Feb 20, 2026. Each investigator has a profile showing what they cite most.
When was Agile Devices, Inc inspected by FDA?
The inspection ran Feb 17 – Feb 20, 2026, and the Form 483 is dated February 20, 2026.
How do I get the full Form 483 for Agile Devices, 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.