FDA Inspection
HydroCision, Inc.HydroCision, Inc. – FDA Inspection, Apr 16, 2014
Record Details
This FDA Inspection record concerns HydroCision, Inc., with an inspection on April 16, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- HydroCision, Inc.
- Inspection Date
- April 16, 2014
- Product Type
- Devices
View Company Profile
ID · 3a3c18b2-7661-4c36-8435-c146891bdec5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 871352
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of HydroCision, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 7, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 1092412 - 2019-06-07
- 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.