FDA executes an establishment inspection of HealthCorp's manufacturing establishment.The FDA investigators are accompanied throughout the inspection by the Vice President (VP) of Regulatory Affairs for HealthCorp.

The FDA investigators discover gross current good manufacturing practice (cGMP) violations, such as failure to segregate raw materials and components prior to acceptance, failure to perform adequate purchasing controls for the AED, failure to clean and maintain production equipment, failure to perform final acceptance activities for the blood pressure drug and AED, failure to assay all active ingredients of the blood pressure drug, and failure to perform adequate stability studies for the blood pressure drug.The investigators also uncover widespread practices where the Plant Manager, in an effort to make production quotas and qualify for production bonuses, alters manufacturing records to show product approval for commercial distribution but with no acceptance activity and results to support these decisions.As a result of these fraudulent practices, the Plant Manager has shown phenomenal 100% year-over-year production growth over the past 5 years.

The VP of Regulatory Affairs works closely with the VP of Operations and the Plant Manager.The VP of Regulatory Affairs is responsible for dealing with all FDA issues and interactions, and advises the VP of Operations and the Plant Manager of any regulatory problem areas, but has no authority over the manufacturing establishment.

The VP of Operations, located at corporate headquarters in another location, has budgetary authority over the manufacturing establishment.The VP of Operations also has final manufacturing and product acceptance and release authority over all products and can hold up a shipment 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 firing 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.Did the Plant Manager cause the violations to occur within the meaning of the FDCA?Why?