FDA Inspection
Merit Medical Ireland Ltd.Merit Medical Ireland Ltd. – FDA Inspection, Sep 15, 2011
Record Details
This FDA Inspection record concerns Merit Medical Ireland Ltd., with an inspection on September 15, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Merit Medical Ireland Ltd.
- Inspection Date
- September 15, 2011
- Product Type
- Devices
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ID · 65f8935a-3316-4393-ac12-0c8dbcff1b35
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 748653
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.75(a)Documentation
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Other FDA inspections of Merit Medical Ireland Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 4, 2018 | Not classified | Office of Inspections and Investigations | |
| October 26, 2017 | Not classified | Office of Inspections and Investigations | |
| September 5, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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