The FDA's complaint alleges that Pharmaceutical Innovations did not manufacture its products in conformance with current good manufacturing practice (GMP) requirements. In addition, the FDA alleges that the company distributed its products without FDA clearance. Pharmaceutical Innovations' products include ultrasound, mammography, and electrocardiogram gels, as well as scanning pads, according to the FDA.
The agency seized lots of Other-Sonic generic ultrasound transmission gel in 2012 after FDA laboratories found Pseudomonas aeruginosa and Klebsiella oxytoca bacteria, which pose serious risks, the FDA said in an October 3 statement. Infections were reported after the products were used in a Michigan hospital.
"Despite multiple warnings by the FDA over the past three years, and promises to correct the numerous ongoing violations, the defendants continued to violate the law," Melinda Plaisier, FDA associate commissioner for regulatory affairs, said in a statement.
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