Enforcement Actions & Penalties Flashcards

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

Answer: Administrative detention

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

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

Answer: A list of inspectional observations that are not final agency determinations

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

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

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

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.

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?

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

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.

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

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

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

Under the FD&C Act, what legal standard must the government meet to obtain a permanent injunction against a drug manufacturer?

Answer: Clear and convincing evidence of past violations and likelihood of future violations

To obtain a permanent injunction, the government must demonstrate by clear and convincing evidence that violations have occurred and are likely to continue without court intervention.

When FDA issues a Warning Letter, what is the expected company response timeframe per FDA's Regulatory Procedures Manual?

Answer: 30 calendar days

FDA's Regulatory Procedures Manual indicates companies are expected to respond to Warning Letters within 15 working days (approximately 21 calendar days), but FDA generally uses 30 calendar days as the standard response window.