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Command Medical Products' purchasing control procedure was "inadequate" because the firm did not evaluate suppliers' and contractors' adherence to the quality system regulation, said a recent FDA warning letter.
One employee was transported to the hospital and hundreds of others were evacuated after a chemical emergency at Steris Corporation in Millcreek Tuesday afternoon.
The UK-based Medicines and Healthcare products Regulatory Agency (MHRA) has posted a physician safety advisory issued by manufacturer AGA Medical Sept. 8 for the AMPLATZER membranous VSD occluder.
Diagnostic test maker Cytyc Corp. late yesterday said it will make a bid worth $374 million to acquire an Australian company that makes instruments and reagents used to detect cancer.
Wednesday afternoon, Uroplasty, Inc., medical devices company, announced that it has received an approvable letter from FDA relating to its pre-market approval application for Macroplastique Implants for the treatment of female stress urinary incontinence.
A former CEO whose firm sold faulty devices was sentenced Sept. 13 by a federal judge to 10 years in prison and ordered to pay $17.2 million in restitution, according to reports.
Manufacturers of at-home medical devices should consider the unique human factors involved in using such devices, or face the risk of liability lawsuits.