FDA 483 - Philips Medical Systems (Cleveland) Inc - June 04, 2019

Philips Medical Systems (Cleveland) Inc. in Cleveland, OH, was inspected and received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning corrective and preventive actions, complaint handling, and document control. These issues indicate a systemic failure to adequately manage and investigate product-related problems and ensure the integrity of quality records.