AZURE BIOSYSTEMS INC. – FDA Inspection, Jul 2, 2026

Record Details

This FDA Inspection record concerns AZURE BIOSYSTEMS INC., with an inspection on July 2, 2026, issued by the San Francisco District Office, covering medical devices & rad health.

Company: AZURE BIOSYSTEMS INC.
Inspection Date: July 2, 2026
Product Type: Medical Devices & Rad Health
Office: San Francisco District Office
Person: Kevin T. Le (Issuing Officer)

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ID · 22a35e4e-7fcd-4664-bf3c-06e00c4ce48d

Inspection Facts

Inspection number: 1325004
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
ISO 13485:2016 Clause 7.4.1Supplier monitoring and re-evaluation not planned
ISO 13485:2016 Clause 7.4.3Purchased product verification activities are inadequate
ISO 13485:2016 Clause 7.5.6Computer software used in production and service provision not validated
ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented

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FDA Inspection

AZURE BIOSYSTEMS INC.July 2, 2026