FDA Inspection
Merit Medical Ireland Ltd.Merit Medical Ireland Ltd. – FDA Inspection, Sep 5, 2012
Record Details
This FDA Inspection record concerns Merit Medical Ireland Ltd., with an inspection on September 5, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Merit Medical Ireland Ltd.
- Inspection Date
- September 5, 2012
- Product Type
- Devices
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ID · f3bca902-2c1f-4a8c-9e62-c064f02d9ab8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 804060
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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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 15, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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