Enforcement Actions & Penalties Flashcards

Which of the following enforcement outcomes would be considered the MOST severe escalation in FDA's enforcement continuum?

Answer: Criminal prosecution with imprisonment

Criminal prosecution resulting in imprisonment represents the most severe FDA enforcement outcome, reserved for cases involving fraud, intentional violations, or patient harm.

Under 21 CFR 7.49, what is the minimum frequency for FDA to review the status of an ongoing recall?

Answer: At reasonable intervals to determine adequacy, typically every 2–4 weeks for Class I

FDA reviews the status of recalls at reasonable intervals; for Class I recalls this is typically every 2–4 weeks to ensure the recall is effective and timely.

A company executive is individually named in an FDA injunction action. Which of the following is NOT a typical provision that can be imposed on the individual?

Answer: Revocation of the individual's professional medical license

FDA cannot revoke professional licenses — that authority belongs to state licensing boards; FDA can impose personal liability, industry bars, and court appearance requirements.

Under the Prescription Drug Marketing Act (PDMA), what penalty applies to the first offense of trafficking in counterfeit prescription drugs?

Answer: Up to 10 years imprisonment and/or fines

PDMA provides for up to 10 years imprisonment for a first offense of trafficking in counterfeit prescription drugs, reflecting the serious public health risk.

When FDA conducts a 'for cause' inspection following a complaint about a drug product, the inspection authority derives from:

Answer: Section 704 of the FD&C Act, which grants FDA broad inspection authority

Section 704 of the FD&C Act grants FDA the authority to inspect registered facilities, their records, and the means used in manufacturing without needing a warrant in most circumstances.

A drug company submits a CAPA (Corrective and Preventive Action) plan in response to a Warning Letter. FDA determines the response is inadequate. What is FDA's most likely NEXT enforcement step?

Answer: Refer the matter to the Department of Justice for injunction or seizure

When a Warning Letter response is inadequate and violations continue, FDA's standard escalation is referral to DOJ to pursue civil judicial action — seizure or injunction.

Which of the following statements about FDA's use of Consent Decrees is ACCURATE?

Answer: Consent decrees are civil agreements negotiated with DOJ that do not require admission of guilt

Consent decrees of permanent injunction are civil judicial agreements filed in federal court and negotiated with DOJ; they do not constitute criminal convictions or require admissions of guilt.