Company
United StatesInfinity Labs SD, Inc, San Jose, CA – FDA Inspections
Inspection records and compliance data for Infinity Labs SD, Inc in San Jose, California. 3 FDA inspections on record, 2 Form 483s, last inspected June 03, 2026.
Company Profile
This profile covers Infinity Labs SD, Inc based in San Jose, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected June 23, 2021. Last inspected June 3, 2026.
Most cited issue areas
- Corrective action procedures not documented1 inspection
- Documentation1 inspection
- Measuring equipment not adequately calibrated or verified1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 3, 2026 | Not classified | Medical Devices & Rad Health · Project Evaluation: Devices | 1320216 |
| August 21, 2023 | VAI | Medical Devices & Rad Health | 1215567 |
| June 23, 2021 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1145266 |
FDA documents
People (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Infinity Labs SD, Inc
FEI Number
3013944123
Address
1836 Stone Ave, San Jose, California 95125, United States
Country
United States
ID: b3d37efd-15bd-4a45-a9ff-a1a55fe570bb