Enforcement Actions & Penalties Flashcards

Which FDA office has primary responsibility for coordinating national enforcement actions and issuing Warning Letters for drug GMP violations?

Answer: Center for Drug Evaluation and Research (CDER) Office of Compliance

CDER's Office of Compliance has primary responsibility for drug enforcement actions, including issuing Warning Letters for GMP and other drug-related violations.

A pharmaceutical company's product is found to be adulterated because the manufacturing facility lacks adequate controls. The legal basis for seizure would be which section of the FD&C Act?

Answer: Section 501(a)(2)(B) — failure to comply with cGMP

Section 501(a)(2)(B) deems a drug adulterated if the methods, facilities, or controls used in manufacturing do not conform to cGMP requirements.

Import Alert 66-40 is associated with which type of enforcement action?

Answer: Automatic detention of drugs from firms with demonstrated GMP violations

Import Alert 66-40 targets drugs manufactured at facilities with significant GMP deficiencies, placing them on 'detention without physical examination' (DWPE) status.

Under the False Claims Act, a qui tam relator (whistleblower) who successfully brings an enforcement action against a pharmaceutical company may receive:

Answer: Up to 15–30% of the government's recovery

The False Claims Act allows qui tam relators to receive between 15% and 30% of the government's recovery, depending on whether the government intervened in the case.

FDA's 'Untitled Letter' differs from a Warning Letter primarily because:

Answer: Untitled Letters identify violations that do not meet the threshold for regulatory significance requiring immediate action

Untitled Letters address less serious violations that do not meet the threshold for a Warning Letter, requiring a response but not constituting official notice of potential regulatory action.

When FDA pursues a criminal misdemeanor charge under the FD&C Act, the government generally does NOT need to prove:

Answer: That the defendant had actual knowledge of or intent to commit the violation

FD&C Act misdemeanor violations are strict liability offenses; the government need not prove the defendant had knowledge of or intent to commit the violation.

A company is under a consent decree and wants to restart a manufacturing line that was shut down. What is the typical required step before restart?

Answer: Obtain written certification from an FDA-approved independent expert confirming compliance

Most consent decrees require certification by an independent expert (agreed upon with FDA) that the firm has remediated deficiencies before resuming operations covered by the decree.