Use of Potable Water Gets Drugmaker a 483
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.
The agency went on to chide the drugmaker after the July inspection for an investigation into a lot of sevoflurane that failed acidity and alkalinity testing at 36 months.
“Your investigation determined the root cause of the failure to be the degradation of sevoflurane into hydrofluoric acid due to the presence of metal particles,” the form reads. However, that investigation failed to identify the use of potable water as a potential source of the foreign metal particles.
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