STAT+: Pharmalittle: FDA slams company recalling eye drops over manufacturing issues; U.S. funds massive Alzheimer’s research database
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because the usual routine of online meetings, phone calls and deadlines has…
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because the usual routine of online meetings, phone calls and deadlines has returned. You knew this would happen, yes? So to cope, we are firing up the coffee kettle and brewing cups of stimulation. Our choice today is the ever-delightful cinnamon dolce. Please feel free to join us. Or grab a bottle of water, if you prefer. Meanwhile, we have assembled the latest line-up of interesting items for you to peruse. We hope your journey today is meaningful and productive. And as always, please keep in touch. Your tips and insights help the world go around…
Global Pharma Healthcare, whose eye drops have been linked to dozens of serious reactions, failed to follow numerous procedures to ensure its products did not become contaminated, according to a U.S. Food and Drug Administration inspection report obtained by STAT. During a recent visit to the facility in Tamil Nadu, India, agency inspectors found the company failed to take basic steps during sterilization, relied on deficient manufacturing processes and methods to ensure and verify sterility, and lacked adequate systems to create aseptic conditions. The FDA inspected the plant in several weeks ago, shortly after the company began recalling its eye drops over concerns about contamination.
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