Steris fined $1 mil. for failing to submit stability test failure reports to FDA.

Executive Summary

STERIS FINED $1 MIL. FOR FAILING TO SUBMIT STABILITY TEST FAILURE REPORTS TO FDA in Greenbelt, Md. federal court Feb. 5. Steris Laboratories signed a plea agreement in January with the U.S. government, pleading guilty to five counts of failing to submit field alerts and annual reports with FDA for two drugs, prochlorperazine and neomycin/polymyxin B/gramicidin ophthalmic solution. "On several occasions between 1992 and 1995...Steris failed to submit to FDA required field alert reports concerning stability test failures for the drugs," the plea agreement states. Federal Judge Deborah Chasanow sentenced Steris to the maximum fine for the offense.