FDA Inspection
Icecure Medical LtdIcecure Medical Ltd – FDA Inspection, Mar 22, 2023
Record Details
This FDA Inspection record concerns Icecure Medical Ltd, with an inspection on March 22, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 67b8524f-b75a-440a-ab1d-27ac675b3167
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1202363
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
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