FDA Enforcement Actions

Which of the following is NOT an administrative tool FDA may use to enforce the FD&C Act?

• Import Alerts

• Debarments

• Injunctions

• Civil money penalities

Which of the following are within FDA’s enforcement authority?

(Click all that apply).

• Shipment of an active pharmaceutical ingredient (API) from San Antonio, TX to Dallas, TX.

• Sale of Super Imaging Device from ACME, Inc’s California warehouse to Healing Hospital in Chicago, IL

• Shipment of Owie Cure Bandages from Germany to Mexico.

• A Facebook Page advertising The Most Amazing Weight Loss Device Ever for sale in British Colombia.

• Awesome Extraction Device imported from Mumbai, India.

Who is responsible for enforcing the FD&C Act? (Click all that apply).

• FDA

• Department of Justice (DOJ)

• US Customs and Border Production (CBP)

• Federal Trade Commission (FTC)

• Members of the public

What is the maximum criminal fine that can be levied by FDA?

• A. $10,000

• B. $50,000

• C. $500,000

• D. $1,000,000

Under §518(b), FDA can order repair, replacement or refund of devices that present unreasonable health risks. if FDA determines that:

·       The device represents an unreasonable risk of substantial harm to the public health;

·       The device was not designed and manufactured in accordance with the then prevailing state of the art;

·       The risk is not due to negligent installation, maintenance, repair, or use of the device by persons other than a manufacturer, importer, distributor, or retailer; and

·       Notification alone is insufficient, and repair, replacement, or refund is necessary.

• True

• False

Advisory Action Letters include which of the following?

• A. Warning Letters

• B. Untitled Letters

• C. Dear John Letters

• D. Dear Doctor Letters

• A and B

A consent decree is a court order involving and injunction with terms negotiated in advance by the manufacturer and the DOJ.

• True

• False

FDA’s authority is limited to administrative actions must rely on the Department of Justice (DOJ) to enforce certain actions.  Which of the following actions is NOT enforced by DOJ?

• A. Debarment

• B. Seizures

• C. Injunctions

• D. Civil penalty proceedings

• E. Criminal prosecutions

Under the FD&C Act, criminal convictions generally require proof of three elements. Which is NOT one of these?

• A. The article falls within FDA’s jurisdiction

• B. The article was introduced into interstate commerce

• C. The article was used off-label

• D. The article is adulterated or misbranded