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FDA Inspection
•Merit Medical Systems, Inc.•September 25, 2009

Merit Medical Systems, Inc. – FDA Inspection, Sep 25, 2009

Record Details

This FDA Inspection record concerns Merit Medical Systems, Inc., with an inspection on September 25, 2009, issued by the Center for Devices and Radiological Health, covering devices.

Company
Merit Medical Systems, Inc.
Inspection Date
September 25, 2009
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · b69baf39-49fb-415d-b4c0-eacc1e9d5536

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
614326
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices

FDA Citations

1
  1. 21 CFR 820.100(a)(3)Identification of actions needed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Merit Medical Systems, Inc.

12
DateClassificationOfficeProject area
September 9, 2024Not classifiedDallas District Office
January 15, 2019Not classifiedDallas District Office
October 25, 2018Not classifiedDallas District Office
January 19, 2018Not classifiedDallas District Office
September 27, 2016VAICenter for Devices and Radiological HealthCompliance: Devices
View all 12 other inspections on the company page
Other documents for Merit Medical Systems, Inc.
  • FDA Inspection 1250853 - 2024-09-09
  • FDA Inspection 1097035 - 2019-01-15
  • FDA Inspection 1109788 - 2018-10-25
  • FDA Inspection 1087233 - 2018-01-19
  • FDA Inspection 988792 - 2016-09-27

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