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Failure to validate its products or to establish procedures that demonstrate its acupressure bracelets for nausea were manufactured according to specifications were among the 13 quality system lapses observed during a March 29 to April 1 FDA inspection of MumEase’s Charlotte, North Carolina facility. Read More
The pandemic forced the FDA to be far more innovative in its efforts to inspect device and drug manufacturing facilities, and the agency plans to incorporate these new modalities into its site surveillance process going forward. Read More
Johnson & Johnson (J&J) plans to spin off its over-the-counter consumer products unit from its more lucrative prescription drugs and medical devices division, splitting itself into two publicly traded companies within the next 18 to 24 months. Read More
Devicemaker YFS Pharma did not investigate or keep detailed records of complaints it received about its Lubricity dry mouth sprayer, FDA investigators observed during an inspection of the company’s Buffalo, N.Y., facility. Read More
The kinds of data that will need to be measured and analyzed in process validation fall into two basic categories: attributes and variables. A thing can have many attributes — traffic lights have three colors, for instance — but in quality assurance, says Dan O’Leary, president of Ombu Enterprises, the focus tends to be on two attributes, conforming and nonconforming. Read More
An FDA inspection of a Philips Respironics facility in Pennsylvania has turned up problems that will delay the company’s replacement of millions of its ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. Read More
HHS withdrew a temporary policy yesterday that directed the FDA not to enforce its premarket review requirements for laboratory developed COVID-19 tests — an emergency policy that was put in place to get tests quickly into use during the pandemic. Read More