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BTE Form 483 Includes Repeat Issues From 2012

October 28, 2013
BTE Technologies landed a Form 483 with repeat observations from a 2012 inspection, including failure to monitor or trend service complaints. The Hanover, Md., company planned to verify the effectiveness of a corrective action for breaking U-shaped handles by monitoring service complaints to see if handles are still breaking. But by the date of a May 13 to June 5 inspection, service complaints had not been monitored or trended for that reason, despite the issue being opened in December 2012, the form says.
The GMP Letter