UPS Healthcare November Lexicon Quiz

A Consent Decree is the ultimate legal action which may be taken by FDA on pharma and med device companies who have not heeded warning letters. It is the ultimate failure on the part of manufacturers to uphold quality and compliance with GMP. True or false?

Form 483 is issued when an investigator has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act. True or false?

An IRB is any board, committee or other groups formally designated by the government to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects. True or false?

What does IRB stand for?