FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Utah Devicemaker Written Up for Audit Conflicts, Servicing Reports

Nov. 4, 2019
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A Park City, Utah device manufacturer was hit with a Form 483 over quality audit and device servicing deficiencies.

The agency inspected the Rocky Mountain Research facility from July 15-16 and, following a review of internal audit records, found that audits were being performed by the company’s president, who had direct responsibility for the activities being audited.

In addition, seven of the eleven service reports reviewed during the agency’s visit did not include retesting to ensure they met specifications following servicing.

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