CRAP Enforcement Actions & Penalties 2

Question 1

Which FDA enforcement action requires a company to stop manufacturing and distributing a product immediately without a court order?

Accepted Answer

Administrative detention

Answer

Administrative detention allows FDA to detain suspect products immediately without court involvement to prevent their movement in commerce.

Question 2

A company receives an FDA Form 483 during an inspection. What is the legally correct characterization of this document?

Accepted Answer

A list of inspectional observations that are not final agency determinations

Answer

FDA Form 483 lists inspectional observations but explicitly states they are not final agency determinations of regulatory violations.

Question 3

Under 21 CFR Part 7, what distinguishes a Class I recall from a Class II recall?

Accepted Answer

Class I involves a reasonable probability of serious adverse health consequences; Class II involves remote probability

Answer

Class I recall involves a reasonable probability that use of the product will cause serious adverse health consequences or death, while Class II involves a remote probability of adverse consequences.

Question 4

What is the maximum civil monetary penalty per violation under the Drug Supply Chain Security Act (DSCSA) for failure to comply with product tracing requirements?

Accepted Answer

$10,000 per violation up to $1,000,000 per proceeding

Answer

DSCSA provides for civil monetary penalties of up to $10,000 per violation, not to exceed $1,000,000 for all violations adjudicated in a single proceeding.

Question 5

Which of the following best describes a 'seizure' as an FDA enforcement tool?

Accepted Answer

A court-ordered civil action to physically remove adulterated or misbranded goods from commerce

Answer

Seizure is a civil judicial action filed in federal district court that physically removes adulterated or misbranded goods from interstate commerce.

(CRAP) Certified Regulatory Affairs Professional Practice Test

(CRAP) Certified Regulatory Affairs Professional Practice Test

CRAP Enforcement Actions & Penalties 2