Why is the Center for Biologics Evaluation and Research (CBER) notified

Why is the Center for Biologics Evaluation and Research (CBER) notified in the case of a transfusion-related fatality?
a.   To recall all banked units
b.   To disclose the name of the deceased
c.   To determine if appropriate corrective action has been taken to prevent recurrence
d.   To report all reagent lot numbers used in typing deceased patient


Biological products are defined as any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component (or derivative allergenic products), or analogous product applicable to the prevention, treatment, or cure of disease or injuries of man. Which specific product was missing in the original PHS statute?
a.   Vaccine           c.   Antitoxin
b.   Blood component   d.   Virus


The FDA-directed civil action that calls for removal of products from distribution channels is known as:
a.   injunction.   c.   prosecution.
b.   seizure.   d.   quarantine.