FDA Inspection
Hiossen Inc.Hiossen Inc. – FDA Inspection, Apr 12, 2017
Record Details
This FDA Inspection record concerns Hiossen Inc., with an inspection on April 12, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · dd809078-dc01-4693-922a-8058a0426732
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1007913
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Hiossen Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 16, 2012 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Hiossen Inc.
- FDA Inspection 831555 - 2013-04-18
- FDA Inspection 781029 - 2012-05-16
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.