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Both businesses grew quickly, but Ameridose was the bigger suc- cess story. Neither company made its sales figures public, but according to several sources, Ameridose would employ nearly 400 workers by 2011 and gross more than $400 million annually. It was on contract with several GPOs. NECC would employ about 50 work- ers and gross more than $30 million. The safety practices at Ameridose once again fell far short of the marketing promises. According to a congressional investigation, FDA received numerous complaints. In Ameridose's first year, an unnamed source told FDA, "I strong- ly suspect ... they are ignoring (Good Manufacturing Practices) when preparing these products. I fear a large-scale epidemic of serious infections may occur." FDA inspected Ameridose in late 2007 and again in the summer of 2008. By that time the firm was making more than 600 products and counted as customers about 500 hospital pharmacies in 49 states. Inspectors found that, as with NECC, none of the products Ameridose made were linked to individual prescriptions. Also, Ameridose was ship- ping products before receiving test results confirming strength and sterility. FDA took a fentanyl sample for testing and found that it was way too strong. FDA officials immediately asked for a recall. After reviewing the report, one compliance officer e-mailed her col- league in the District: "This case bothers me. ... Perhaps we should be thinking of getting a health hazard evaluation and getting the firm to recall as many of their products as we can. A vast majority of their products are sterile injectable opioids. Super potency is a serious con- cern." "We have a history with this firm," wrote Michael Levy, director of the FDA's Office of Compliance, in another e-mail. "Maybe it's time for reinspection and possible follow-up enforcement action?" Nothing 1 5 2 • O U T PA T I E N T S U R G E R Y M A G A Z I N E • J U L Y 2 0 1 6