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www.fdanews.com/articles/163761-cr-bard-form-483-discusses-storage-area-control-dhr

C.R. Bard Form 483 Discusses Storage Area Control, DHR

April 11, 2014
C.R. Bard received an FDA Form 483 for storage area control and other manufacturing issues. The company had not performed temperature mapping studies to find “cold spots, hot spots, dead spots.”
The GMP Letter