Products Seized By FDA At Steris Labs

The US Food and Drug Administration has filed a seizure action againstall products manufactured by Steris Laboratories, a subsidiary of the US generics drugmaker Schein Pharmaceuticals. The move comes after the FDA noted certain deficiencies in terms of Good Manufacturing Practices after inspections of Steris' manufacturing facility in Phoenix, Arizona.

Steris received a warning letter from the FDA in early 1998 and says it is surprised by the seizure action, as it believed that progress had been made in discussions that have taken place since. This would appear to not be the case, and Schein's senior vice president and general counsel, Paul Feuerman, has noted that halting manufacturing and distribution of Steris products, "which account for a very significant portion of the company's sales and profits," is somewhat unfortunate.

However, he added that the FDA generally uses seizures as preludes to negotiations of consent orders, which "would allow us to formalize a process of resolving the open issues."