Search the FDA Debarment List of individuals and entities debarred or sanctioned for abuse, fraud, or integrity issues.
HealthProviders DB is updated monthly with the Food and Drug Administration (FDA) Debarment List, ensuring it is always current.
Enter an NPI number, license number, or provider name in the search field below to search the FDA Debarments and Clinical Investigators Disqualifications.
Alternatively, you can also search the Provider Profiles.
About the FDA Debarment List
The Federal Food, Drug, and Cosmetic Act, 21 U.S. Code §335a — Debarment, temporary denial of approval, and suspension, and 21 U.S. Code §335b — Civil penalties, as published in the Federal Register, records individuals and companies prohibited from providing services, participating in transactions, or conducting general business with the U.S. Food and Drug Administration for conduct by:
- A firm relating to the development or approval, including the process for development or approval, of any abbreviated drug application or,
- An individual convicted of developing or approving any drug product or otherwise relating to any drug product under the Federal Food, Drug, and Cosmetic Act.
This list aims to help businesses comply with FDA regulations and protect public health. It does this by preventing those with a history of regulatory noncompliance from engaging in any FDA-related activities.
The FDA Debarment List is compiled per 21 U.S. Code §335a(e).
For healthcare businesses, associating with a debarred individual or firm can have various consequences. These consequences often range from legal repercussions to monetary losses, reputational damages, and contract terminations.
One of the simplest ways to mitigate the risk of these events is to do an FDA debarment list search. Compliance officers should implement this check as part of their company’s internal vetting processes. Conducting an FDA debarment list search should involve several key steps.
The first step is to immediately halt any ongoing contracts with the individual or vendor found after completing an FDA debarment list check. Compliance officers also have to consider that the debarment list is meant to prevent companies from hiring someone who is banned from working within the drug industry, unknowingly or accidentally.
Once an observation is made, an organization should report the discovery immediately, as hiring someone on the FDA debarment list can result in fines of up to $250,000 per individual and $1,000,000 per organization.
In some cases, you may be required to report your findings to regulatory authorities. This is especially true if your organization has checked the FDA’s debarment list of clinical investigators and continues to work with a debarred person without realizing it. In this case, the FDA’s Office of Criminal Investigations will likely conduct a further investigation into the violation.