FDA Inspection
HydroCision, Inc.HydroCision, Inc. – FDA Inspection, May 8, 2009
Record Details
This FDA Inspection record concerns HydroCision, Inc., with an inspection on May 8, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- HydroCision, Inc.
- Inspection Date
- May 8, 2009
- Product Type
- Devices
View Company Profile
ID · 83b36ef3-5840-44af-8d82-4f6cd8918a74
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 586534
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.25(b)Training
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.40(a)Document review, approval documentation
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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 |
| April 16, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 7, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for HydroCision, Inc.
- FDA Inspection 1092412 - 2019-06-07
- FDA Inspection 871352 - 2014-04-16
- FDA Inspection 771019 - 2012-03-07
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