FDA warns Philips of violations at facilities making ultrasounds, medical systems

WASHINGTON – The U.S. Food and Drug Administration (FDA) has sent Royal Philips CEO Roy Jakobs a warning letter saying the devices made at three of its facilities are adulterated and fail to conform with current good manufacturing practice requirements. The facilities are: 

• Philips Ultrasound in Bothell, Wash.; 

• Philips Ultrasound in Reedsville, Pa.; and 

• Philips Medical Systems in Eindhoven, the Netherlands 

The FDA outlined nine violations, including: 

• Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. 

• Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. 

• Failure to establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution. 

• Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), including analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. 

Philips told Bloomberg it took the warning very seriously, and it has responded to the FDA. The company also told Bloomberg the products mentioned in the FDA’s letter continue to be manufactured and sold, and it does not expect any material commercial impact from the warning.