In one of the more eye-opening warning letters issued recently by the Food and Drug Administration, an Indian drug maker was rebuked for failing to correct serious quality-control problems, some of which apparently management knew about thanks to an anonymous email.
Moreover, the letter to Ipca Laboratories documented a laundry list of manufacturing issues at three different plants, which either make finished pharmaceutical products or active ingredients that are supplied to many other drug makers. Among its domestic customers are Merck, Pfizer, and AstraZeneca.
And unlike other agency warnings, the Jan. 29 missive that the FDA sent to Ipca also included at least two instances where company employees acknowledged either that certain problems were “critical” or admitted that falsifications took place, according to the letter.
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“They complain the FDA has singled them out for especially tough inspections, which occur too frequently and haphazardly, depriving them of the opportunity to make substantive changes.”
This cracked me UP! How much “opportunity” is needed to stop cheating and lying?