FDA warns Philips after issues arise at multiple manufacturing facilities
The U.S. Food and Drug Administration recently alerted imaging giant Philips after inspections unearthed issues at multiple manufacturing facilities. Meanwhile, the Amsterdam-headquartered company said Tuesday it has already taken action to begin correcting these issues.
Authorities posted the notice online Tuesday, with violations discovered at plants in Pennsylvania, Washington and the Netherlands. Concerns included failure to establish procedures for receiving and reviewing complaints, along with failure to submit required reports within 10 working days after initiating a product correction or removal.
“You should know that this letter is not intended to be an all-inclusive list of the violations at these facilities,” FDA Deputy Director Matthew G. Hillebrenner wrote in a letter dated Sept. 9. “The specific violations noted in this letter … may be symptomatic of serious problems in your firm’s manufacturing and quality management systems,” he added later. “Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.”
Other issues included failure to establish procedures for validating device design and the lack of defined processes for inspections, tests and other verification activities. On the former, the FDA highlighted issues with the IntelliSpace Cardiovascular software, version 8, used by cardiology departments to store and manage images across multiple modalities. The pregnancy-related update supports imaging studies of up to five fetuses, providing measurements, calculations and report generation, whereas an earlier version only allowed for a single fetus per mother. However, despite multiple new modifications, Philips’ facility failed to include these product requirements in its safety-risk specifications. This would have helped ensure any hazards associated with these new functions are “analyzed and evaluated, and that appropriate risk control measures are implemented as needed.”
Both U.S. facilities produce Philips ultrasound devices. These included the EPIQ Elite Ultrasound system, manufactured in Bothell, Washington; ultrasound transducers made in Reedsville, Pennsylvania; and the IntelliSpace Cardiovascular and eCareManager, produced in Eindhoven, the Netherlands.
In a statement shared Tuesday, Philips noted that the FDA conducted “intensive” inspections across nine of its facilities. Six of the investigations led to no observations from the U.S. agency. Violations at the other three sites pertained to processes, procedures and documentation, with Philips already working to address such issues.
The company has been conducting a multiyear program to systematically enhance quality, address historical issues and “transform our patient safety culture.” Philips has previously faced safety issues in the past, including a class action lawsuit over recalled sleep apnea machines tied to hundreds of deaths, which resulted in a $1.1 billion payout last year.
A representative emphasized the products mentioned in the warning letter continue to be manufactured and sold. Philips does not expect these issues to impact its commercial performance, though the firm’s shares were down 6% Tuesday amid news of the violations.
“Philips takes this warning letter very seriously and has submitted a response to the agency in accordance with regulatory requirements,” a representative said in a statement shared with Radiology Business Oct. 28. “As the FDA notes, we have already taken action to address earlier observations. We are determined to resolve these issues to the full satisfaction of the FDA with the needs of patients and clinicians central to our focus and we are committed to continuously improving our documentation, processes and procedures in close collaboration with all global regulators.”
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.