Steris Hasn't Solved Manufacturing Violations: FDA

Law360, New York (October 21, 2008, 12:00 AM EDT) -- The U.S. Food and Drug Administration published a letter Tuesday that it had sent to Steris Corp., warning that the medical-device sterilization company wasn't complying with “good manufacturing” regulations and could face penalties.

The FDA's Sept. 25 letter to Steris said that the company hadn't adequately responded to the agency's prior assesment of violations found during an inspection this summer of its Coventry, R.I. plant.

The agency's inspection uncovered violations including sending products to customers with “deviations” and failing to meet federal requirements before shipping out...
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