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

An FDA inspection of Philips Medical Systems (Cleveland) Inc. was conducted from May 7 to June 4, 2019. This directed follow-up inspection focused on a Class II medical device manufacturer that was in the process of ceasing manufacturing operations at its Cleveland facility. The inspection, guided by FDA regulations for medical device manufacturers (e.g., 21 CFR 820.100(b)), served as a follow-up to previous observations, including an FDA-483 issued in August 2017 and a 'Voluntary Action Indicated' classification from October 2018. At the conclusion of the current inspection, an FDA-483 was issued with four main observations. Key issues included inadequate documentation of Corrective and Preventive Action (CAPA) activities and results, with specific deficiencies in the remediation of service records and customer feedback. Additionally, the firm failed to promptly investigate complaints representing Medical Device Report (MDR) events. Complaint procedures were not fully established, encompassing concerns with classifying certain alerts and handling 'non-Complaints.' Lastly, unapproved documents were found in use as Quality System records. Management acknowledged all observations and promised corrective actions, though they requested additional time to assess and determine appropriate implementation timeframes. The company is actively transitioning manufacturing, complaint handling, and recall functions to its Haifa, Israel, and Suzhou, China, facilities.