Company
United StatesGener8, San Jose, CA – FDA Inspections
Inspection records and compliance data for Gener8 in San Jose, California. 2 FDA inspections on record, 1 Form 483, last inspected July 29, 2025.
Company Profile
This profile covers Gener8 based in San Jose, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected May 5, 2023. Last inspected July 29, 2025.
Most cited issue areas
- Servicing - Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 29, 2025 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1276873 |
| May 5, 2023 | VAI | Medical Devices & Rad Health | 1206007 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Gener8
FEI Number
3012157621
Address
2560 Junction Ave, San Jose, California 95134, United States
Country
United States
ID: bc8384a9-3f8f-44f1-9960-40f550abbb96