HealthCorp is a small company in Sunnyvale, California that buys bulk active pharmaceutical ingredients for blood pressure drugs, blends them with excipients, and fills the capsules.The company also buys bulk automatic external defibrillators (AEDs) and relabels them under their private label.HealthCorp primarily distributes their product in the State of California and sells their product to internet customers on their website.

FDA has received reports of adverse events associated with HealthCorp products - low blood pressure resulting in dizziness and fainting for the blood pressure drug, and unexpected malfunctions of the AEDs causing a failure to deliver electric shocks needed to treat sudden cardiac arrest or arrhythmias - from consumers across the U.S.

Part I

FDA attempts to inspect HealthCorp's manufacturing establishment in Sunnyvale, California but Mr. Robert Jones, the President refuses to permit FDA to inspect the facility claiming that HealthCorp only sells their products to California residents.

Discuss FDA's inspectional authority and whether it has federal jurisdiction to inspect HealthCorp's manufacturing establishment.What recourse does FDA have if Mr. Jones continues to refuse an inspection?

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.

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.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?

Part III

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.

3.Identify the adulteration or misbranding drug and device cGMP violation.

Assume that all active pharmaceutical ingredients, excipients, ingredients, components and parts for the blood pressure drug and AED device are obtained by HealthCorp from California suppliers.Also, HealthCorp has a finished goods distribution center in Nevada to fulfill internet orders.

The FD&C Act's basic purpose is to protect the public.So FDA seeks to control the adulterated products and prevent further manufacturing and commercial distribution of the adulterated drugs and devices.Assuming little or no voluntary recall cooperation from HealthCorp, FDA initiates a seizure and condemnation action to remove all drug and device products that can be located from the market.The product is immediately "seized" when the suit is started.FDA also seeks an injunction to prevent further manufacturing and commercial distribution of violative products from HealthCorp's manufacturing establishment and commercial distribution from the finished goods distribution center.

Consider the following situations and state whether FDA can seize or enjoin the violative products and give reasons why.

4.Are the violative drugs seizable on HealthCorp's premises?Why?

5.Are the violative devices seizable on HealthCorp's premises?Why?

6.Are the violative drugs seizable at any of HealthCorp's local San Francisco retailers?Why?

7.Are the violative devices seizable at any of HealthCorp's local San Francisco retailers?Why?

8.Are the violative drugs seizable at HealthCorp's Nevada finished goods distribution center?Why?

9.Are the violative devices seizable at HealthCorp's Nevada finished goods distribution center?Why?

10.Can FDA seek an injunction of HealthCorp's manufacturing establishment to prevent it from manufacturing and distributing violative products if products have not been yet shipped in interstate commerce?Why?If so, what prohibited act applies?

11.Can FDA seek an injunction of HealthCorp's manufacturing establishment to prevent it from manufacturing and distributing violative product if FDA determines that products have been sold on the internet or collects a bill of lading showing that finished products have been shipped in interstate commerce or are destined to be shipped to out-of-state customers?Why?If so, what prohibited act applies?

12.Can FDA seek an injunction of HealthCorp's finished goods distribution center in Nevada to prevent it from further commercial distribution of violative drugs and devices?Why?If so, what prohibited act applies?