Compliance & Enforcement (2024)

One of the highest priorities of the FDA’s Center for Veterinary Medicine is our post-market activities. Our goal is to assure that animal food is safe, made under sanitary conditions, and properly labeled, that animal drugs, animal devices, and animal food additives are safe and effective,and in cooperationwith other agenciesthat no harmful residues in food-producing animals enter the human food supply. We oversee the animal products industry for compliance by developing and issuing regulations and guidance documents, providing education and training, and pursuing regulatory and enforcement actions, as warranted, in collaboration with our federal and state regulatory partners.

On this page:

Outbreaks and Advisories
Regulatory Actions - News Releases
Compliance Programs

Compliance and Enforcement Tools

• Advisory Actions
• Administration Actions
• Enforcement Actions

Additional Resources
Questions?

Outbreaks and Advisories

Public health advisories are written by the FDA to alert the public about pressing human and/or animal health concerns related to products regulated by the Center for Veterinary Medicine (CVM). While some of the advisories may involve product recalls, CVM advisories are separate from product recall press releases that are written by a recalling company.

Go to Outbreaks and Advisories

Regulatory Actions – News Releases

• July 9, 2024 -U.S. Compounding, Inc. Pleads Guilty To Multiple Fraud Offenses And Company Vice President Indicted In Scheme To Distribute Drugs Nationally Using False Prescriptions
• May 9, 2024 -Covetrus Sentenced for Criminal Misbranding of Prescription Drugs
• February 26, 2024 -Family Dollar Stores LLC Pleads Guilty to Holding Consumer Products under Insanitary Conditions, Agrees to Pay $41.675 Million in Connection with Rodent-Infested Warehouse

Back to the top

Compliance Programs

FDA's Compliance Programs provide instructions to FDA personnel for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other laws administered by FDA. The FDA’s Center for Veterinary Medicine has compliance programs that span topics such as animal drug and device manufacturing, unapproved animal drugs, drug residues, bovine spongiform encephalopathy, medicated and non-medicated feed manufacturing, feed contaminants and more.

When FDA obtains information that an FDA-regulated product poses a risk to the public health, our first priority is to determine whether the product should be removed from the marketplace and if so, to take swift action to ensure public notification and removal. This is typically accomplished most expeditiously by voluntary corrective efforts by the responsible firm(s). FDA can utilize advisory actions, administrative actions and enforcement actions when a firm’s voluntary action is not rapid, complete, or the firm is uncooperative.

Advisory Actions

Untitled Letters

Untitled letters address violations that do not meet the threshold of regulatory significance for a Warning Letter or enforcement action.

Warning Letters

Warning letters are advisory in nature and are the FDA’s principal means of notifying regulated industry about violations of regulatory significance, with the goal of stimulating prompt voluntary corrective action. Warning letters are not final agency action. They communicate the agency’s position, but they do not commit FDA to taking enforcement action. Additionally, there is no requirement for FDA to send a warning letter before the agency initiates enforcement action.

Firms receiving a warning letter have 15 business days to respond to the agency with a plan to correct the noted violations. Firms are also given the opportunity to dispute whether they are in violation of the FD&C Act, and to provide supporting documentation for the agency’s consideration. FDA will review any supporting evidence as well as the firm’s the action plan, where applicable, and determine whether it is likely to be sufficient to correct the violations. The agency also monitors the firm’s subsequent activities as appropriate to ensure that they stay in compliance with all applicable regulations.

Back to the top

Administrative Actions

Inspections

The FDA conducts inspections of regulated facilities to determine a firm's compliance with applicable laws and regulations. While some inspections are conducted routinely as a surveillance measure or in the pre-approval of a New Animal Drug Application (NADA), the FDA also conducts “for-cause” inspections to investigate a specific problem that has come to the agency’s attention. To search for inspections of FDA-inspected firms and their classifications, visit FDA’s Inspection Classification Database Search.

FDA Form 483

FDA investigators issue an FDA Form 483 to firm management at the conclusion of an inspection when they observe any conditions that in their judgment may constitute violations of the FD&C Act and related authorities. FDA Form 483 is presented and discussed with the firm’s senior management to notify them of objectionable conditions. Each observation is read and discussed so that the firm fully understands the observations and what they mean. These reports are not an all-inclusive list of every possible legal violation and only capture what FDA investigators saw during the course of a single inspection. The FDA Form 483 is not a final agency determination of whether any condition observed is in violation of the FD&C Act or its implementing regulations.

FDA encourages firms to respond to the FDA Form 483 in writing with their plan to address the cited objectionable conditions and then implement that plan expeditiously. Examples of recently issued FDA Form 483s are available in ORA's Electronic Reading Room.

Recalls

Recalls—of which there are three types—are actions taken by a firm to remove a product from the market. Recalls may 1) be conducted on a firm's own initiative, 2) by formal FDA request, or 3) by FDA order under FDA’s mandatory recall authority.

FDA works with industry and state partners to publish press releases and other public notices about recalls that may present a significant or serious risk to the consumer or user of the product. FDA regulations require public notification for all Class I and some Class II recalls. FDA posts these press releases on its website in order to increase the reach of the notification to the public. However, not all recalls have press releases or are posted on the Recalls webpage.

FDA also classifies each recall after assessing the potential public health impact of the product at issue. The weekly Enforcement Report lists all recalls after they have been classified by FDA. For more information about FDA’s product recall authority, process and classification guidelines, see FDA 101: Product Recalls.

Import Refusals

FDA-regulated products can be refused entry into the U.S. if they do not comply with FDA’s laws and regulations. Reasons for refusal include, but are not limited to, entries that appear to be:

• adulterated, meaning the product is contaminated, is not safe, or does not otherwise meet applicable standards;
• misbranded, meaning the labels contain false or misleading information;
• an unapproved new drug;
• forbidden or restricted for sale.

For information on specific products which have been refused, you can view the FDA Import Refusal Report (IRR).

Suspension of Food Facility Registration

Facilities that manufacture, process, pack or hold food for distribution in the United Sates must register with the FDA. When a food product presents a reasonable probability of serious adverse health consequences or death to humans or animals, FDA can suspend a facility’s registration to prevent it from introducing into interstate commerce food from the facility until FDA determines that adequate grounds do not exist to continue the suspension actions required by the order.

Debarment & Disqualification

For certain serious violations of the FD&C Act, FDA may debar or disqualify an individual or company. Debarment and disqualification prohibit the person or organization from engaging in the type of activity in which the violation occurred. For example, a company convicted of a felony for importing adulterated food may be debarred from importing food into the United States for a specified period of time. A clinical investigator who submits fraudulent data in support of an application for new animal drug approval may be disqualified from participation in future studies to support new animal drug approvals.

Back to the top

Enforcement Actions

Product Seizures

A product seizure is an action brought against an FDA-regulated product because it is adulterated and/or misbranded within the meaning of the FD&C Act. Seizures are intended to remove products from commerce and place them under custody of a court, until a court can decide whether they are violative as alleged. The FDA works through the court system to request a seizure, which is then carried out by the U.S. Marshals.

Injunctions

An injunction is an order issued by the court requiring a defendant to perform an act which he or she is obligated to perform, but refuses to do; or forbidding the defendant from doing a specified act which he or she is threatening or attempting to do. Injunctions can be temporary or permanent. In certain cases, FDA may request through the U.S. Department of Justice that the court grant an injunction to stop or prevent violation of the law, such as to prevent violative products from entering interstate commerce and to correct the conditions that caused the violation to occur.

When an injunction is granted, FDA has a continuing duty to monitor the injunction and to advise the court if the defendant(s) fail to obey the terms of the consent decree. If a defendant violates the terms of the consent decree, the agency may initiate civil or criminal contempt proceedings or other regulatory action.

To learn more about Preliminary Injunctions, Temporary Restraining Orders and Permanent Injunctions, see Chapter 6 of the FDA Regulatory Procedures Manual.

Criminal Prosecution

FDA’s Office of Criminal Investigation conducts criminal investigations of illegal activities involving FDA-regulated products, arresting those responsible, and bringing them before the U.S. Department of Justice for prosecution. Under the Federal Rules of Criminal Procedure, the defendant(s) may be punished for having violated the law and/or a court order.

Back to the top

Additional Resources

• Compliance Policy Guides – Veterinary Medicine
• CVM Advisory Action Letters
• Enforcement Reports
• FDA Regulatory Procedures Manual (RPM), July 2018
• FDA Investigations Operations Manual (IOM), 2019
• CVM FOIA Electronic Reading Room
• ORA FOIA Electronic Reading Room
• FDA Electronic Reading Room
• Inspection Classification Database

Questions concerning CVM’s Compliance activities can be addressed to:

Division of Drug Compliance or Division of Food Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine
U.S. Food and Drug Administration
12225 Wilkins Ave., MPN 4, Room 176
Rockville, MD 20855
Telephone: (240) 402-7002
FAX:(240) 276-9241
Email: [email protected]

Back to the top