HealthProviders DB imports the Food and Drug Administration (FDA) Debarment List each month, so the database is always up to date.
The debarment data is normalized and matched with the Healthcare Providers’ Profile as Exact or Possible matches, greatly simplifying your research.
Uncover an unparalleled solution to effortlessly and simultaneously search OIG Exclusions, SAM Exclusions, State Exclusion Lists, FDA Debarment, and Clinical Investigators—Disqualification Proceedings—all in one powerful platform!
Avoid potential Civil Monetary Penalties (CMP) with HealthProviders DB automated exclusion monitoring.
The FDA Debarment List includes individuals and entities debarred or sanctioned for abuse, fraud, or integrity issues under sections 306(a) or (b) of the Federal Food, Drug, and Cosmetic Act 21 U.S. Code §335a — Debarment, temporary denial of approval, and suspension or 21 U.S. Code §335b — Civil penalties as published in the Federal Register.
Healthcare organizations must screen new hires and regularly monitor current employees, as well as the individuals and entities with whom they do business, to avoid potential Civil Monetary Penalties.
About the FDA Debarment List
The FDA Debarment List 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 ensure the protection of public health. It does this by preventing those with a history of regulatory non-compliance from engaging in FDA-related activities altogether.
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 the 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 penalties.
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 being aware of it. In this case, the FDA’s Office of Criminal Investigations will likely conduct a further investigation into the violation.
The FDA Debarment List Data Collected
| Field Name | Description |
|---|---|
| Last Name | Person last name |
| First & Middle Names | Person’s first name and middle name |
| Effective Date | The effective date |
| End/Term of Debarment | The debarment term |
| Volume Page.pdf | Link to the Debarment Order PDF |