FDA 483 - Flexicare Medical Ltd. - August 02, 2018

An FDA inspection of Flexicare Medical Ltd., a medical device manufacturer in Rhondda Cynon Taff, UK, revealed significant deficiencies in their quality system. The firm failed to submit Medical Device Reports (MDRs) in a timely manner, lacked adequate procedures for Corrective and Preventive Actions (CAPA), and exhibited issues with design transfer and design validation for their Infiant CPAP device. Additionally, complaint investigations were found to be inadequate, failing to fully assess the significance of device failures.