FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Kansas Devicemaker Hit for Lack of Quality System Management

Jan. 11, 2019

The FDA served Kansas device manufacturer OCCK a Form 483 for issues with its Salina, Kansas facility’s quality system management.

The investigator, who inspected the firm from August 8-9, 2018, found that the facility had not documented the appointment of a management representative to ensure that quality system requirements are fulfilled. The management representative was also expected to report to facility management on the firm’s quality system performance.

The firm was also called out for device history records, which lacked identification labels and labeling, and its reviews of document control procedures.

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