FDA Inspection
Illumina, Inc.Illumina, Inc. – FDA Inspection, Jun 22, 2026
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.
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ID · d796d53a-511b-4e45-b34d-79ff5994aa4a
Inspection Facts
- Inspection number
- 1312448
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 7.3.1Design and development procedures not documented
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
- ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of Illumina, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 3, 2017 | Not classified | San Francisco District Office |
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