FDA Inspection
Acteon, Inc.Acteon, Inc. – FDA Inspection, Feb 23, 2017
Record Details
This FDA Inspection record concerns Acteon, Inc., with an inspection on February 23, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · b5c2f273-9cd5-408c-9812-6d5dc84b1f8a
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1002018
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Acteon, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 10, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 12, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 9, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Acteon, Inc.
- FDA Inspection 905889 - 2014-12-10
- FDA Inspection 756655 - 2011-12-12
- FDA Inspection 595046 - 2009-07-09
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.