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www.fdanews.com/articles/159837-use-of-potable-water-gets-drugmaker-a-483

Use of Potable Water Gets Drugmaker a 483

November 1, 2013
FDA investigators observed employees at Piramal Critical Care’s Bethleham, Pa., plant using potable water in the manufacture of finished drugs, which resulted in a Form 483. During the manufacture of inhalational anesthetic drugs isoflurane and sevoflurane, Piramal did not conduct testing for microbial contamination in the water supply, which was used to “clean product contact surfaces such as bulk transfer tanks, finished product stainless steel drums and processing equipment,” the three-observation form states.
Drug GMP Report