FDA Inspection 1303582 - Agile Devices, Inc. - February 20, 2026

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Record Details

This FDA Inspection record concerns Agile Devices, Inc., with an inspection on February 20, 2026, issued by the Center for Devices and Radiological Health, covering devices.

Company: Agile Devices, Inc.
Inspection Date: February 20, 2026
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 33cfbded-d915-462e-9627-4df1ef42e645

Violation Codes5

ISO 13485:2016 Clause 4.1.5ISO 13485:2016 Clause 7.3.9ISO 13485:2016 Clause 8.2.1ISO 13485:2016 Clause 8.2.2ISO 13485:2016 Clause 8.5.2

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