Company
United StatesPublic company, NASDAQ: ILMNIllumina, Inc. (NASDAQ: ILMN), San Diego, CA – FDA Inspections
Inspection records and compliance data for Illumina, Inc. in San Diego, California. 12 FDA inspections on record, 5 Form 483s, last inspected June 23, 2026. Publicly traded as NASDAQ: ILMN.
Company Profile
This profile covers Illumina, Inc. based in San Diego, California, United States.
FDA Inspection History
- FDA inspections
- 12
- OAI
- 0
- VAI
- 2
- NAI
- 5
- Unclassified
- 5
- Form 483s
- 5
- Warning letters
- 0
First inspected September 11, 2013. Last inspected June 23, 2026.
Most cited issue areas
- Acceptance status1 inspection
- Design review - documentation1 inspection
- Environmental control Lack of or inadequate procedures1 inspection
FDA inspections (12)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 23, 2026 | Not classified | Medical Devices & Rad Health | 1312600 |
| August 16, 2019 | Not classified | Medical Devices & Rad Health | 1157012 |
| October 5, 2017 | Not classified | Medical Devices & Rad Health | 1045094 |
| October 5, 2017 | Not classified | Medical Devices & Rad Health | 1045055 |
| December 14, 2016 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 994780 |
| November 10, 2016 | VAI | Medical Devices & Rad Health · Project Evaluation: Devices | 993038 |
| November 10, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 993037 |
| October 21, 2016 | Not classified | Medical Devices & Rad Health | 996332 |
| August 31, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 941365 |
| August 28, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 941363 |
| September 13, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 849532 |
| September 11, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 848650 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Illumina, Inc.
Stock ticker
ILMN
Exchange
NASDAQ
Share price
$207.61
Market cap
$31.4B
Price as of
November 6, 2026
FEI Number
3003218906
Address
5200 Illumina Way, San Diego, California 92122, United States
Country
United States
ID: 6c2f2a3d-e3f1-4f43-b2b6-34ec89cbd76b