CRAP Enforcement Actions & Penalties 2 — Questions and Answers
Question 1: Which FDA enforcement action requires a company to stop manufacturing and distributing a product immediately without a court order?
- Consent decree
- Warning letter
- Mandatory recall
- Administrative detention (Correct answer)
Correct answer: Administrative detention
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?
- A formal enforcement action requiring immediate corrective action
- A list of inspectional observations that are not final agency determinations (Correct answer)
- An official notice of violation triggering penalty calculations
- A preliminary injunction notice requiring court response
Correct 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.
Question 3: Under 21 CFR Part 7, what distinguishes a Class I recall from a Class II recall?
- Class I involves cosmetics; Class II involves drugs
- Class I involves a reasonable probability of serious adverse health consequences; Class II involves remote probability (Correct answer)
- Class I is voluntary; Class II is mandatory
- Class I requires public press release; Class II does not
Correct 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.
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?
- $1,000 per violation up to $100,000 per proceeding
- $10,000 per violation up to $1,000,000 per proceeding (Correct answer)
- $50,000 per violation
- $250,000 per violation
Correct 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.
Question 5: Which of the following best describes a 'seizure' as an FDA enforcement tool?
- A court-ordered civil action to physically remove adulterated or misbranded goods from commerce (Correct answer)
- An administrative action to suspend a company's operating license
- A criminal prosecution of company executives
- A mandatory recall initiated by the company under FDA oversight
Correct 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.
Question 6: Under the FD&C Act, what legal standard must the government meet to obtain a permanent injunction against a drug manufacturer?
- Beyond a reasonable doubt
- Clear and convincing evidence of past violations and likelihood of future violations (Correct answer)
- Preponderance of evidence of a single significant violation
- Reasonable suspicion of ongoing violations
Correct 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.
Question 7: When FDA issues a Warning Letter, what is the expected company response timeframe per FDA's Regulatory Procedures Manual?
- 7 calendar days
- 15 business days
- 30 calendar days (Correct answer)
- 60 calendar days
Correct 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.
CRAP Enforcement Actions & Penalties 2
Which FDA enforcement action requires a company to stop manufacturing and distributing a product immediately without a court order?