FDA Inspection
CORIN MEDICAL, LTD.CORIN MEDICAL, LTD. – FDA Inspection, Mar 5, 2015
Record Details
This FDA Inspection record concerns CORIN MEDICAL, LTD., with an inspection on March 5, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- CORIN MEDICAL, LTD.
- Inspection Date
- March 5, 2015
- Product Type
- Devices
View Company Profile
ID · 50c450fa-9807-4c0a-a862-5300645c17fe
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 919617
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.80(e)Documentation
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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Other FDA inspections of CORIN MEDICAL, LTD.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 27, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 12, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 18, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 3, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 30, 2008 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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