Part II 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