FDA Inspection
Medtronic CryoCath LPMedtronic CryoCath LP – FDA Inspection, Oct 27, 2016
Record Details
This FDA Inspection record concerns Medtronic CryoCath LP, with an inspection on October 27, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e79fd9e7-9dde-4f3f-91d3-b3d7fc73d89b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 992735
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Medtronic CryoCath LP
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2024 | VAI | Office of Inspections and Investigations | Compliance: Medical Devices |
| August 15, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 16, 2011 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| December 10, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Medtronic CryoCath LP
- FDA Inspection 1253044 - 2024-10-31
- FDA Inspection 844849 - 2013-08-15
- FDA Inspection 761562 - 2011-12-16
- FDA Inspection 633459 - 2009-12-10
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