Company
United StatesAgendia, Inc., Irvine, CA – FDA Inspections
Inspection records and compliance data for Agendia, Inc. in Irvine, California. 4 FDA inspections on record, 1 Form 483, last inspected May 29, 2024.
Company Profile
This profile covers Agendia, Inc. based in Irvine, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected August 12, 2011. Last inspected May 29, 2024.
Most cited issue areas
- Design validation - user needs and intended uses1 inspection
- Document change records, maintained.1 inspection
- Investigation of device failures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 29, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1240483 |
| April 12, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1167584 |
| August 22, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1022495 |
| August 12, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 747287 |
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
Agendia, Inc.
FEI Number
3007297853
Address
22 Morgan, Irvine, California 92618, United States
Country
United States
ID: 3f132159-b8a0-4c5c-be76-3023266dde9b