FDA Inspection
CryoSurgery, Inc.CryoSurgery, Inc. – FDA Inspection, Mar 9, 2023
Record Details
This FDA Inspection record concerns CryoSurgery, Inc., with an inspection on March 9, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · efa85c01-dba3-48f7-b9c3-dd5855ccccc0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1200019
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CryoSurgery, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 17, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 5, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 7, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 23, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for CryoSurgery, Inc.
- FDA Inspection 963510 - 2016-03-17
- FDA Inspection 865858 - 2014-02-05
- FDA Inspection 810602 - 2012-12-07
- FDA Inspection 683647 - 2010-09-23
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