FDA 483 - Medivance Instruments Ltd. - August 11, 2022

Medivance Instruments Ltd., a medical device manufacturer in London, was cited for significant quality system deficiencies during an FDA inspection. Observations included failure to submit a timely Medical Device Report for a serious injury, inadequate complaint handling, and a lack of established procedures for CAPA, design changes, software validation, and device history records. These issues indicate a broad breakdown in the firm's quality management system.