Compliance & Enforcement
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 cooperation with other agencies that 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 and Enforcement Tools
Outbreaks and Advisories
- Updated January 20, 2023 - FDA Cautions Horse Owners Not to Feed Recalled Lots of Top of the Rockies Alfalfa Cubes due to Reports of Illness and Death
- August 5, 2022 - FDA Cautions Pet Owners Not to Feed Certain Lots of Darwin’s Natural Pet Products Due to Salmonella
- April 26, 2022 - FDA alerts customers to voluntary recall of compounded drugs due to sterility issues by Drug Depot, LLC, dba APS Pharmacy
Regulatory Actions – News Releases
- April 26, 2023 - NYC Mother and Son Charged with Interstate Shipment of Misbranded Animal Drugs
- March 28, 2023 - Couple Pleads Guilty to Smuggling $2 Million in Pesticides and Veterinary Drugs
- March 28, 2023 - Midwest Veterinary Supply Pleads Guilty to Misbranding Veterinary Drugs
- February 28, 2023 - FDA Takes Action to Restrict Unlawful Import of Xylazine
- January 26, 2023 - FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward
- December 23, 2022 - Collegeville Man Found Guilty for Scheme to Sell Fraudulent Canine Cancer-Curing Drugs to Pet Owners
- December 9, 2022 - Thoroughbred Racehorse Trainer Jason Servis Pleads Guilty In Federal Doping Case
- November 16, 2022 - New York Veterinarian And Racehorse Trainers Sentenced To Prison In Federal Doping Case
- September 8, 2022 - Horse Doping Seller Sentenced To 42 Months In Manhattan Federal Court
- July 29, 2022 - Illegal Pharmacy Operator Sentenced to Federal Prison
- July 27, 2022 - North Carolina Woman Pleads Guilty to Selling Unapproved Covid-19 Remedies
- July 11, 2022 - Horse Doping Drug Supplier Sentenced To 11 Years In Prison
- June 22, 2022 - Amherst County Veterinarian Sentenced for Opioid Theft
- May 26, 2022 - FDA Warns Four Companies for Illegally Selling CBD Products Intended for Use in Food-Producing Animals
- May 11, 2022 - New York Racehorse Veterinarian And Standardbred Trainer Plead Guilty In Federal Doping Case
- May 6, 2022 - Horse Doping Drug Seller Convicted In Manhattan Federal Court
- May 4, 2022 - FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products
- April 21, 2022 - Lyndonville Woman Sentenced for Selling Misbranded Pet Medications
- April 20, 2022 - Supervisor at Long Island Drug Manufacturer Sentenced to Prison for Theft of Medical Products
- March 28, 2022 - Operator of Portland Animal Rescue Business Charged for Role in Wire Fraud Conspiracy, Illegally Dispensing Animal Drugs
- March 28, 2022 - Federal judge enters consent decree against New Jersey raw animal food manufacturer
- March 3, 2022 - Harness Trainer Christopher Oakes Sentenced To 3 Years In Federal Doping Case
- February 2, 2022 - Horse Doping Drug Supplier Convicted In Manhattan Federal Court
- January 24, 2022 - Former Veterinarian Pleads Guilty to Drug Charges
- January 5, 2022 - Operator of Illegal Veterinary Pharmacy Pleads Guilty
- December 17, 2021 - Prolific Thoroughbred Trainer Sentenced To Five Years In Federal Doping Case
- November 22, 2021 - Court Enjoins California Company from Manufacturing and Distributing Adulterated Sterile Animal Drugs
- September 10, 2021 - Owner Of Illegal Racehorse Doping Websites Sentenced To 18 Months In Prison
- April 23, 2021 - Owner Of Illegal Racehorse Doping Websites Pleads Guilty In Manhattan Federal Court
- March 9, 2021 - Operator of Racehorse Doping Websites Sentenced to 18 Months in Prison
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.
Compliance and Enforcement Tools
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.
Untitled letters address violations that do not meet the threshold of regulatory significance for a Warning Letter or enforcement action.
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.
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—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.
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.
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.
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.
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.
- 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 (HFV-210) or Division of Food Compliance (HFV-230)
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