The VP of Operations. located at corporate headquarters in another location. has budgetary authority over the manufacturing establishment. The VP of Operations also has nal manufacturing and product acceptance and release authority over all products and can hold up ashipment if there is a problem. The VP of Operations reports directly to the President of HealthCorp and has line authority over the Plant Manager. The President has ultimate authority over all operations and activities of HealthCorp, but delegates budgetary and personnel authority to the VP of Operations. Only the Plant Manager has hiring and ring authority over the plant personnel. It is the Plant Manager's responsibility to implement recommendations of the VP of Regulatory Affairs if approved by the VP of Operations. As a result of HealthCorp's gross cGMP violations and deliberate attempts to engage in fraudulent behavior. FDA charges the President, VP of Regulatory Affairs, and VP of Operations in a criminal action for shipment of adulterated drugs and devices in interstate commerce. 1. In their defense. the defendants claim that they did not have knowledge of the situation and that it was really the Plant Manager's fault. Who is responsible for causing the prohibited acts under these facts? a) President? Why? b) VP of Regulatory Affairs? Why? c) VP of Operations? Why? 2. Did the Plant Manager cause the violations to occur within the meaning of the FDCA? Why