FDA 483 - Seriously Clean, Ltd. - March 28, 2018

Seriously Clean Ltd in Nixa, MO, was inspected regarding its medical device manufacturing quality system. The inspection revealed widespread and significant deficiencies, with the firm failing to establish or maintain numerous critical procedures for device master records, device history records, medical device reporting, corrective and preventive actions, complaint handling, management review, nonconforming product control, purchasing controls, and quality audits. These observations indicate a fundamental lack of a compliant quality system.