FDA Inspection 1312448 - Illumina, Inc. - June 22, 2026

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Record Details

This FDA Inspection record concerns Illumina, Inc., with an inspection on June 22, 2026, issued by the San Francisco District Office, covering medical devices & rad health.

Company: Illumina, Inc.
Inspection Date: June 22, 2026
Product Type: Medical Devices & Rad Health
Office: San Francisco District Office

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ID · d796d53a-511b-4e45-b34d-79ff5994aa4a

Violation Codes6

21 CFR 803.17(a)(1)ISO 13485:2016 Clause 4.1.2ISO 13485:2016 Clause 7.3.1ISO 13485:2016 Clause 8.2.2ISO 13485:2016 Clause 8.3.1ISO 13485:2016 Clause 8.5.2

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