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 New England District Office, covering medical devices & rad health.

Company: Agile Devices, Inc.
Inspection Date: February 20, 2026
Product Type: Medical Devices & Rad Health
Office: New England District Office

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ID · 1a3e2317-5dc4-404d-ada2-4da3135b3679

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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