FDA Inspection
Agena Bioscience, Inc.Agena Bioscience, Inc. – FDA Inspection, Jun 13, 2023
Record Details
This FDA Inspection record concerns Agena Bioscience, Inc., with an inspection on June 13, 2023, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 8b8c5f71-624a-45ce-8a1d-3b1b1354d384
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1209246
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Enforcement
- Warning Letter
Other FDA inspections of Agena Bioscience, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 12, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Agena Bioscience, Inc.
- FDA Inspection 1084872 - 2019-03-20
- FDA Inspection 918333 - 2015-03-12
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.