Question
As a result of the gross cGMP violations, HealthCorp's blood pressure drugs have wide variations in the concentration of the active pharmaceutical ingredients, which can
As a result of the gross cGMP violations, HealthCorp's blood pressure drugs have wide variations in the concentration of the active pharmaceutical ingredients, which can deviate 30% from the USP uniformity standards.It is likely that individuals taking these capsules will not receive the intended dosage.In addition, the supplier of the printed circuit boards (PBCs) for the AEDs has an uncontrolled manufacturing process resulting in open solder joints resulting in a 25% failure rate of the PCBs.HealthCorp's inadequate purchasing controls will not be able to determine if the received PCBs have this manufacturing defect that will result in product malfunctions causing a failure to deliver electric shocks.
1.Identify the adulteration or misbranding drug and device cGMP violation.
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