CRAP Enforcement Actions & Penalties 3

Question 1

Which federal statute authorizes FDA to pursue criminal prosecution of individuals who commit prohibited acts under the FD&C Act, even without proof of fraudulent intent?

Accepted Answer

Both the Park Doctrine and Dotterweich doctrine apply separately

Answer

Both United States v. Dotterweich (1943) and United States v. Park (1975) established the Responsible Corporate Officer doctrine allowing criminal liability without proof of personal wrongdoing.

Question 2

A medical device manufacturer repeatedly violates GMP regulations. FDA seeks to bar the company from future FDA submissions. This action is called:

Accepted Answer

Debarment

Answer

Debarment prohibits individuals or firms convicted of certain felonies from submitting or assisting in applications to FDA.

Question 3

Under 21 CFR Part 16, what type of proceeding does FDA use for most administrative enforcement actions involving civil penalties?

Accepted Answer

Regulatory hearing process

Answer

21 CFR Part 16 establishes the regulatory hearing process, an informal but structured process FDA uses for various administrative enforcement proceedings.

Question 4

FDA's Application Integrity Policy (AIP) is triggered when FDA finds:

Accepted Answer

Potentially fraudulent data or misrepresentations in regulatory submissions

Answer

AIP is invoked when FDA has information that raises significant questions about the integrity of data or information in pending or approved applications.

Question 5

What is the key difference between a 'voluntary' and a 'mandatory' recall under current US law?

Accepted Answer

Voluntary recalls are initiated by the company; mandatory recalls are ordered by FDA and currently only authorized for certain product categories

Answer

Most recalls are voluntary, initiated by the firm; FDA has mandatory recall authority for infant formula, medical devices, and tobacco products but relies primarily on voluntary cooperation for other products.

(CRAP) Certified Regulatory Affairs Professional Practice Test

(CRAP) Certified Regulatory Affairs Professional Practice Test

CRAP Enforcement Actions & Penalties 3