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Medical Devices / Inspections and Audits

Virginia Devicemaker Failed to Properly Review Quality System

Jan. 7, 2019

The FDA came down on Midlothian, Virginia device manufacturer and repacker PARI Respiratory Equipment, citing the firm in a Form 483 for failing to properly conduct quarterly quality system management reviews.

Specifically, the agency learned that for years, the company’s senior manager did not attend the meetings. The FDA investigator reviewed attendance records in July 2018 and found that the last meeting the senior manager attended was in January 2016.

The firm’s management review procedures require that PARI’s management representative conduct quarterly quality system management reviews with senior management in attendance.

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