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Medical Devices / Inspections and Audits

FDA Cites Minnesota Devicemaker for Quality Issues

June 27, 2019

A Minnesota device manufacturer’s quality agreement with a contract manufacturer was not up to the FDA’s standards and netted the firm a Form 483.

During a Feb. 27-March 5 inspection, the agency found issues with a quality agreement between Proximagen and a contract manufacturer, such as a lack of clarity over the contractor’s role in  customer complaint management and adverse event reporting.

The firm also did not designate a management representative to monitor and give updates on the facility’s quality system prior to August 2018.

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