Philips de Costa Rica S.R.L. – FDA 483, May 5, 2022

An FDA inspection of Philips de Costa Rica S.R.L., a medical device manufacturer in Alajuela, Costa Rica, revealed a significant deficiency in their quality system. The firm failed to adequately establish and implement procedures for corrective and preventive actions (CAPA). Specifically, their Process FMEA records did not properly define the 'Effect of Failure' as required by their own risk management procedures, indicating a breakdown in their risk assessment and CAPA processes.