philips received Warning statement A report from the FDA in February, the agency posted on Tuesday, found that an inspection of the tech giant's manufacturing facility in Suzhou, China, which makes CT and ultrasound inspection systems, showed that the quality systems It said it was found not to comply with the regulation's good manufacturing requirements.
In an inspection of the facility in October, FDA found that the equipment had „foreign material“ in that the methods used to develop, manufacture, package, store, and install the products did not comply with good manufacturing proactive requirements under federal law. It was found that there was „contamination“. Rules.
Specifically, the agency said the company failed to „verify the injection molding process used by the supplier of the custom-manufactured Philips Incisive CT Patient Interface Monitor (PIM) data cable.“
The Philips Incisive CT PIM is considered a medical device, and manufacturers like Philips file medical device reports when they become aware of a device that can cause or has caused death or serious injury. is needed.
According to the agency, Philips failed to submit a written report to FDA regarding the modification or removal of the equipment, specifically regarding three violations: PIM cable connection failure that caused loss/error of ECG gate signal; Diagnosis is delayed. A software defect causes images to appear upside down or inverted. Software defects can result in image artifacts and inaccurate image orientation.
After the October inspection, Philips responded to the FDA's complaints, but the FDA said in a warning letter that those responses were insufficient and that Philips had not provided appropriate documentation to demonstrate that appropriate changes were made. He said there was no.
Phillips has 15 days to respond to the letter, which states that other federal agencies may consider the company's compliance when considering awarding federal contracts. ing.
bigger trends
Formerly Philips came under fire The FDA announced that 561 deaths have been reported in connection with the tech giant's infections since 2021. Recalled ventilators and machines For the treatment of obstructive sleep apnea syndrome.
Philips filed 30 medical device reports from 2011 to April 2021, eight of them from the United States, related to foam breakage or deterioration in PE-PUR machines.
Philips notified FDA of its intent to pursue local litigation in April 2021 and formally filed a correction and takedown report in June 2021. started a recall Targeting over 5 million devices.
In a statement, the company said that after issuing public comments regarding the recall, „Between April 2021 and April 2022, the number of MDRs filed by Philips Respironics with the FDA increased by approximately 20,500. Then, through October 2022. In the last six months, Philips Respironics has applied.'' approximately 70,500 MDR, and approximately 8,300 MDR in November and December 2022. ”
At the end of January this year, Philips agreed Urges regulators to halt sales of PE-PUR and similar devices in the United States
Last month, a federal district court entered a consent decree against the manufacturer, requiring it to provide partial refunds or new or reworked/repaired devices to patients affected by the recall. .
The order also restricted Philips from manufacturing or selling new CPAP machines, BiPAP machines, or other equipment at its facilities in California and Pennsylvania until certain requirements are met.
Earlier this week, the company Q1 earnings reportThis included notification that Philips Respironics had resolved claims filed in U.S. courts and potential claims submitted through the Census Registry.
The company plans to pay $1.1 billion to individuals who say they were injured by CPAP or ventilators, with payments to be distributed in 2025.