U.S. Food and Drug Administration
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FDA Enforcement Activities

Recalls

Actions taken by firms to remove problem products from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.

Warning Letters

Sent from FDA to regulated companies about regulatory issues.

Enforcement Report

A weekly report of FDA regulatory activities.

Import Alerts

Identify problems with commodities and shippers and provide guidance to FDA field investigators about import coverage.

Import Detentions

Notices about imported products that FDA has detained because appear to be out of compliance with the Federal Food, Drug, and Cosmetic Act.

Online Sales of Medical Products

"Cyberletters" and other information about actions involving Websites whose offers to sell prescription drugs online may be illegal.

Debarment List

Individuals or firms barred from participating in the drug industry because they have been convicted of crimes related to FDA's regulation of drugs.

Disqualified/Restricted/Assurances List for Clinical Investigators

Clinical investigators who have at one time been disqualified, restricted, or have agreed to certain restrictions on their conduct in future studies. If an investigator has been reinstated or restrictions have expired, it is so noted.

Public Health Service Administrative Actions

Researchers who have had administrative actions imposed against them by the Office of Research Integrity (ORI).

Notices of Initiation of Disqualification Proceedings and Opportunity to Explain

Letters issued by FDA when it believes that a clinical investigator repeatedly or deliberately violated FDA's regulations governing the proper conduct of clinical studies involving investigational products or submitted false information to the sponsor.

Dietary Supplement Enforcement Report

FDA Pursues Aggressive Enforcement Strategy (June 30, 2003)

FDA is charged with protecting American consumers by enforcing the Federal Food, Drug, and Cosmetic Act and several related public health laws.

When a problem arises with a product regulated by FDA, the Agency can take a number of actions to protect the public health. Initially, the agency works with the manufacturer to correct the problem voluntarily. If that fails, legal remedies include asking the manufacturer to recall a product, having federal marshals seize products if a voluntary recall is not done, and detaining imports at the port of entry until problems are corrected. If warranted, FDA can ask the courts to issue injunctions or prosecute those that deliberately violate the law. When warranted, criminal penalties--including prison sentences--are sought.


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