FDA Compliance and Enforcement Information
On this page:
- I. Regulatory compliance and enforcement actions
- II. Procedures for identifying violations
- III. Procedures for notification of violations
- IV. General enforcement information
- V. Transparency reports on compliance and enforcement activity
FDA has responsibility for enforcing a broad range of statutory and regulatory requirements. FDA is taking steps to make its enforcement activities more transparent. For example, FDA has posted a a searchable database that includes the name and address of inspected facilities, the date(s) of inspection, type of FDA-regulated products involved, and final inspectional classification, as well as a summary of the most common inspectional observations.
FDA has also placed a number of enforcement-related datasets on the Data.gov website. These include datasets for major food recalls, including the peanut and shell egg recalls, and a dataset providing information about web sites that are or were illegally marketing unapproved, uncleared, or unauthorized products related to the 2009 H1N1 flu virus. FDA has also launched a redesigned webpage and phone app to permit consumers to search more easily and quickly for food and other product recalls, market withdrawals, and safety alerts. Go to Improved Recall Search Display. In addition, FDA can assist interested parties, in certain instances, in addressing marketplace confusion over the identity of products subject to a recall. Assisting Interested Parties in Addressing Marketplace Confusion Over the Identity of Products Subject to Recall.
I. Regulatory compliance and enforcement actions
FDA has authority to take both administrative and judicial actions to protect the public from dangerous and illegal products, to punish persons and companies who violate the law, and to deter violations. Administrative actions are decided upon and taken by the agency in the first instance, although they can be appealed to federal courts. Judicial actions are decided upon and taken by federal courts, at the request of the Department of Justice and FDA.
- Administrative actions include product recalls, debarment of individuals or companies who have been convicted of felonies, withdrawals of product approvals, license revocations, and disqualification of clinical investigators.
- Judicial actions include seizures of violative products, injunctions, criminal prosecutions, and certain civil money penalties.
The following links provide information on many of the specific administrative and judicial actions that have been taken by or on behalf of FDA.
A. Administrative actions
- Import refusal reports
- Biologic license revocations/suspensions
- Orders of retention, recall, destruction, and cessation of manufacturing related to human cell, tissue, and cellular and tissue-based products
- Disqualified, restricted, restrictions removed, assurance lists for clinical investigators
- Recalls and market withdrawals:
- FDA debarment list
B. Judicial actions
II. Procedures for identifying violations
To find out whether companies are complying with FDA’s requirements, FDA can carry out investigations of different kinds, including routine and for-cause inspections of companies and individuals who manufacture, distribute, or test regulated products, and criminal investigations. (FDA may also learn of potential violations through other sources, such as referrals from other regulatory or law enforcement organizations.)
The following links provide information about inspections and investigations FDA has conducted.
A. Domestic and foreign inspections
- Frequently requested inspection documents
- Center for Devices and Radiological Health Inspections Database
- Center for Biologics Evaluation and Research
- Nonclinical laboratories inspected under Good Laboratory Practices since FY90
- Inspection Observations page
- Inspections Database page
B. Criminal investigations
- H1N1 Flu-Related Enforcement Dataset:
- Notifications informing consumers about specific counterfeit medicines and cargo thefts of FDA-regulated products that may pose health risks to consumers, and that have been uncovered in FDA investigations:
III. Procedures for notification of violations
notifies companies and individuals of potential violations of FDA’s requirements, generally in advance of taking enforcement actions, through several mechanisms. Warning Letters inform recipients of significant regulatory violations documented during inspections or investigations that may lead to an enforcement action if the violation is not promptly corrected. Untitled Letters are initial correspondence citing violations that do not necessarily meet the criteria for a Warning Letter. Import Alerts contain information given to the FDA district offices concerning new problems affecting particular imports. Notices of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) are sent to clinical investigators notifying them that the agency is proposing to disqualify them from participating in future FDA-regulated investigations.
IV. General enforcement information
The following links are to sources that gather in one place information about all the enforcement actions FDA has undertaken in a given period of time, or that specific FDA Centers have undertaken.
V. Transparency reports on compliance and enforcement activity
- On April 22, 2014, FDA released a report recommending ways to enhance the transparency and public accessibility of the agency's compliance and enforcement data.
- On January 31, 2012, FDA released a new report presenting eight initiatives adopted by the Commissioner to explore avenues for making FDA’s compliance and enforcement data more accessible and user-friendly.
- On October 3, 2011, FDA released a report that contains eight draft proposals to improve access to FDA's compliance and enforcement data.