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A consent decree of permanent injunction against Philips Respironics restricting the production and sale of new CPAP and BiPAP machines and mechanical ventilators at three U.S. facilities has been entered by the U.S. District Court for the Western District of Pennsylvania. Read More
Senate Majority Whip Dick Durbin (D-Ill.) and Senator Mike Braun (R-Ind.) have urged the FDA to take “swift” action to update its enforcement tools to address the alarming proliferation of dangerous and misleading social media content promoting prescription drugs. Read More
A company-initiated recall of nearly 68,000 Olympus bronchoscopes is now deemed class I by the FDA because of the risk of endobronchial combustion, which could cause serious injuries or death. Read More
The manufacturer of eye drops linked to more than 80 adverse reactions, including 14 cases of blindness and four deaths, received a 15-page FDA warning letter calling the company out for lack of product sterility as well as inadequate product formulation, data integrity lapses and more. Read More
Fresenius Medical Care has recalled some of its hemodialysis machines for the potential of exposing patients to a harmful chemical, and Olympus has recalled an insufflation unit — and the FDA has deemed both these recalls as class I, the most serious type of recall because of the potential for serious side effects including death. Read More
Panacea Biotec, a maker of generic and specialty pharmaceuticals as well as vaccines, got rapped with a nine-observation Form 483 for inadequate oversight of aseptic procedures and environmental conditions for sterile drugs and poor training of employees, among other lapses. Read More
In this edition of Quick Notes, we cover another Philips ventilator recall, GE HealthCare and Novo Nordisk collaborate to develop a diabetes and obesity ultrasound treatment and 510(k) clearance for Insulet’s Omnipod 5 App for iPhone. Read More
In the latest FDA blow to Biocon Biologics, a July inspection of its insulin production facility in Johor, Malaysia, has been classified by the agency as “Official Action Indicated” (OAI), the most serious inspection classification and one step short of a warning letter or other enforcement action. Read More
The FDA has deemed Hamilton Medical’s recall of certain of its ventilators as class I, the most serious type of recall, as a potential leak could cause the machine to stop delivering air, which could lead to serious injury or death. Read More
The former CEO of Utah-based device maker Dolor Technologies will be sentenced Nov. 8 on misdemeanor charges related to failure to seek FDA approval for a device to treat migraine headaches. Read More
LXR Biotech received a warning letter from the FDA for having methods, facilities, controls for manufacturing, processing or holding its drug product that do not conform to GMPs, after the company’s response to a Form 483 included a statement that it no longer manufactures drugs. Read More