FDA Inspection
Illumina, Inc.Illumina, Inc. – FDA Inspection, Aug 28, 2015
Record Details
This FDA Inspection record concerns Illumina, Inc., with an inspection on August 28, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Illumina, Inc.
- Inspection Date
- August 28, 2015
- Product Type
- Devices
View Company Profile
ID · ac0cf899-6931-489d-b7eb-b849872b8dd0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 941363
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Illumina, Inc.
11| Date | Classification | Office | Project area |
|---|---|---|---|
| June 23, 2026 | Not classified | Los Angeles District Office | |
| August 16, 2019 | Not classified | Los Angeles District Office | |
| October 5, 2017 | Not classified | Los Angeles District Office | |
| October 5, 2017 | Not classified | Los Angeles District Office | |
| December 14, 2016 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Illumina, Inc.
- FDA Inspection 1312600 - 2026-06-23
- FDA Inspection 1157012 - 2019-08-16
- FDA Inspection 1045094 - 2017-10-05
- FDA Inspection 1045055 - 2017-10-05
- FDA Inspection 994780 - 2016-12-14
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