FDA Inspection
Illumina, Inc.Illumina, Inc. – FDA Inspection, Nov 10, 2016
Record Details
This FDA Inspection record concerns Illumina, Inc., with an inspection on November 10, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ca3dffc8-1a3f-4093-a72e-60e80b6ede59
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 993038
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.86Acceptance status
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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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