STERIS' (STE) Albert Browne Receives FDA Warning Letter Related to Chemical Indicators Made in the UK

June 12, 2012 8:24 AM EDT Send to a Friend
In a Form 8-K dated May 31st but just filed with the SEC, STERIS (NYSE: STE) disclosed the company's Albert Browne Limited subsidiary received a warning letter from the U.S. Food and Drug Administration regarding chemical indicators manufactured in the United Kingdom. These devices are intended for the monitoring of certain sterilization and other processes.

The FDA warning letter states that the Agency has raised concerns regarding operational business processes. We do not believe that the concerns are related to product performance and are not a result of Customer complaints. We continue to work with the FDA to resolve the issues raised as diligently as possible. We do not currently believe that the impact of this event will have a material adverse effect on our financial results.


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