FDA Inspection
HydroCision, Inc.HydroCision, Inc. – FDA Inspection, Jun 7, 2019
Record Details
This FDA Inspection record concerns HydroCision, Inc., with an inspection on June 7, 2019, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 875c5fcb-ddac-48e0-9ade-1dc4c85d56a3
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1092412
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(d)Design output - documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of HydroCision, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 16, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 7, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 8, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for HydroCision, Inc.
- FDA Inspection 871352 - 2014-04-16
- FDA Inspection 771019 - 2012-03-07
- FDA Inspection 586534 - 2009-05-08
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.