Question
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
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.
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?
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