Agile Devices, Inc.

Form 483

Newton Center, MassachusettsFEI 3023167283Issued February 20, 2026

View FDA's Record for This Firm

Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3023167283.

Observations5

Issue DateFebruary 20, 2026

StatusNo Warning Letter

Related Inspections2

Establishment Details

Firm: Agile Devices, Inc.
Location: Newton Center, Massachusetts
FEI Number: 3023167283
Product Type: Devices
Issue Date: February 20, 2026
Country: United States

Inspection History, 2023 to 2026

NAI1

VAI1

NAI means No Action Indicated. VAI means Voluntary Action Indicated.

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Agile Devices, Inc. FDA Form 483, Newton Center, Massachusetts, February 20, 2026