FDA Inspection
Merit Medical Systems, Inc.Merit Medical Systems, Inc. – FDA Inspection, Dec 7, 2017
Record Details
This FDA Inspection record concerns Merit Medical Systems, Inc., with an inspection on December 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ee31bbee-8c8e-4560-9ec2-8c386e4af098
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1034745
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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Other FDA inspections of Merit Medical Systems, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 2, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Merit Medical Systems, Inc.
- FDA Inspection 895678 - 2014-09-16
- FDA Inspection 678701 - 2010-09-02
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