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
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