FDA Inspection
Agendia, Inc.Agendia, Inc. – FDA Inspection, Aug 22, 2017
Record Details
This FDA Inspection record concerns Agendia, Inc., with an inspection on August 22, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · ce84f4ee-8b75-46a9-8808-a4fc6cbad512
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1022495
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.40(b)Document change records, maintained.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Agendia, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 29, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 12, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 12, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Agendia, Inc.
- FDA Inspection 1240483 - 2024-05-29
- FDA Inspection 1167584 - 2022-04-12
- FDA Inspection 747287 - 2011-08-12
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.