FDA Debarment Lists

Data through 2 October 2026.

On the drug applications list

152

Mandatory, section 306(a)

146

Permissive, section 306(b)

6

On the drug imports list

63

On the expired list

61

Copy taken

9 November 2026

Applications list, by year the order took effect

2026

5

2025

2

2024

11

2023

9

2022

6

2021

8

2020

10

Before 2020

101

Counts people by the effective date of their first order on the list.

Latest changes in FDA's update log

25 September 2026: Naveed Aslam

revised on applications

25 September 2026: Jeffrey Thies

revised on imports

23 September 2026: Sanjay Kumar

revised on imports

31 August 2026: Rahim R. Shafa

revised on applications and imports

3 August 2026: Angela Anatilde Baquero

revised on applications

3 August 2026: Ricardo Andres Acuna

revised on applications

30 July 2026: Justin Ash

removed on imports

24 July 2026: Francis Esteban Matos

revised on imports

17 June 2026: Andrew Jonathan Morgan

revised on imports

1 June 2026: Rick Shepard

removed on imports

Drug lists only. FDA's log also covers its food import debarment list.

Source: FDA's Debarment List (Drug Product Applications), its Drug Imports and Expired lists, and its update log, read into a snapshot by a script. The links go to the Federal Register notice for each order.

These are the definitions printed under FDA's lists, copied word for word. The symbols appear in FDA's Term column. This tool shows them as the Basis column and the notes in each row.

• ^ Mandatory Debarment (Sec. 306(a))
• % Permissive Debarment (Sec. 306(b))
• * Hearing requested and denied.
• # Acquiesced to Debarment.
• aka Also known as
• NMI No Middle Initial known to be used
• ~ Federal Register Documents dating before 1995 are available via PDF at govinfo.gov
• ** Ms Mary L. Donnelly, of Green Bay City, Michigan, USA (FDA Docket No. 93N-0264), is not to be confused with Dr. Mary Sandra Donnelly, currently affiliated with St. Michael's Hospital of Toronto, Ontario, Canada.
• ***Ashok Patel of Upper Saddle River, New Jersey, USA (FDA Docket No. 92N-0417), is not to be confused with Dr. Ashokkumar Bhailaibhai Patel (a.k.a. Ashok B. Patel), currently affiliated with Radiant Research, St. Louis, Missouri nor with Ashok Shankarbhai Patel of Allegan, MI, currently affiliated with Perrigo Company.
• **** Robert Shulman, of Centerport, NY, USA (FDA Docket No. 93N-0069), is not to be confused with Dr. Robert J. Shulman, currently affiliated with Baylor College of Medicine, Children's Nutrition Research Center, Texas Children's Hospital.
• From the imports list: p Debarment based on a pattern of importing or offering for import.
• From the expired list: + Special Termination of Debarment (Sec. 306(d)(4)(C) and (d)(4)(D)); ++ Order to Withdraw Order of Debarment (debarment terminated) (Sec. 306(d)(3)(B)(i)); !!! Rescission of Debarment Order. The expired list also has one row, “One person removed from list”, for a rescission published in the Federal Register on 16 January 2003(68 FR 2339).

Section 306 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a) lets FDA bar people from working on drug approvals, and from importing drugs. Congress added it in 1992 with the Generic Drug Enforcement Act. Section 306(e) tells FDA to publish each order in the Federal Register and to keep a public list of debarred people, with effective dates and periods, updated at least quarterly (21 U.S.C. 335a). FDA keeps that list on several pages. This tool copies three of them.

The Drug Product Applications list holds 152 people debarred from providing services in any capacity to a company with an approved or pending drug application. The Drug Imports list holds 63 people debarred from importing drugs or offering them for import, under section 306(b)(3)(C) and (D). The Expired list holds 61people whose debarment ended. FDA's firm tables are empty on all three pages, so every entry is an individual.

FDA also publishes a list of food import debarments. It is outside the drug scope of this tool and is not copied.

Name

Last name, then first and middle names, as FDA prints them. Aliases and suffixes are kept.

Effective

The date the debarment takes effect, from FDA's Effective Date column.

Term as FDA lists it

Permanent, or a number of years. FDA's column also carries symbols, which this tool turns into the Basis column and the notations.

Basis

Mandatory (FDA's ^ mark, section 306(a)) or permissive (FDA's % mark, section 306(b)).

Calculated end

Effective date plus the number of years, worked out by this tool for fixed terms on the current lists. FDA does not print an end date, and the order itself governs. For the expired list the column says how the debarment ended.

Federal Register

The volume and page of the notice, linked to the notice where FDA links it, with its publication date.

Other FDA notations

Hearing requested and denied (*), acquiesced to debarment (#), a pattern of importing (p), and any later notice about the same person: a Federal Register correction, a special termination or a withdrawal. FDA's own footnotes about people with common names are copied in full.

FDA says that a later Federal Register notice about someone already on a list is posted after the first listing. The tool folds those rows into the person's entry and shows them in the notes column. 5 people on the current applications list carry one. Today each is a correction to the original notice. On the expired list the later notice is usually the one that ended the debarment: a special termination, or a withdrawal.

One person can also appear on two lists. Rahim R. Shafa is on the applications list with a permanent debarment and on the imports list with a term of 20 years, both from the same Federal Register notice. Each list records a different bar, so the entries differ. Search a name and read every row it returns before drawing a conclusion.

Type a name in either order. “Smith Jerrod” and “Jerrod Smith” return the same row. A year finds every entry with that effective date or Federal Register date. A citation such as 89 FR 42474 finds the entry it supports, including entries whose only later notice is a correction. Words such as permanent, mandatory or 306(b) match the term and the basis.

The list menu starts on the current Drug Product Applications list, the list the certification question points to. Switch it to the imports list, the expired list or all three. The effective year menu counts what is left after your other filters. Each search sets the page address, so a result can be sent as a link.

A search with no result means no row on the selected list matched the text you typed. It does not show that a person was never debarred. The list may be missing a spelling variant, the person may sit on another list, or FDA may have published a notice after the date of this copy.

Section 306(a) is mandatory. FDA must debar an individual convicted of a federal felony for conduct relating to the development or approval of any drug product, or otherwise relating to the regulation of a drug product. For an individual the debarment is permanent (306(c)(2)(A)(ii)). 146 of the 152 entries on the current applications list are mandatory.

Section 306(b) is permissive. FDA may debar an individual convicted of a federal misdemeanor or a state felony relating to drug products, or of a felony involving bribery, fraud, perjury, false statements or falsifying records when the pattern of conduct suggests the person may violate the Act. Section 306(b)(3) adds importing: a felony conviction for conduct relating to importing a drug, or a pattern of importing prohibited controlled substances, or adulterated or misbranded drugs that are missing from, or falsely designated in, an authorized electronic data interchange system. The import provisions came in with the 2018 SUPPORT Act, Pub. L. 115-271.

The statute limits each permissive debarment to five years, and lets FDA run the periods for several offenses one after another (306(c)(2)(A)(iii)). The current applications list shows 6 permissive entries, with terms of 5, 10, 12, 25 years. The order behind one 12-year entry gives its arithmetic: three years for each of four offenses, run consecutively (82 FR 11045). The imports list runs from 5 to 20 years. One name, Rahim R. Shafa, is on both current lists, with different terms.

FDA sends the person a notice proposing debarment and an opportunity to request a hearing. The orders on the list describe the same steps. A 2026 order records that the person had not responded 30 days after receiving the notice, and treats the silence as a waiver of the hearing under 21 CFR part 12. Section 306(i) requires an order made on the record after an agency hearing on disputed issues of material fact. FDA then publishes a final order in the Federal Register with the effective date.

Two of FDA's symbols record how a contested case ended. A * means the person requested a hearing and FDA denied it. A # means the person acquiesced. On the current applications list 21 entries carry the first and 3 the second. In most cases a person can ask a court of appeals to review the order, within 60 days of notification (306(j)).

A fixed term runs out, and the person moves to the expired list. Section 306(d) gives other routes. A person who is not permanently debarred can apply for termination, and FDA has 180 days to grant or deny the application. A reversed conviction requires FDA to withdraw the order. The expired list holds 2 withdrawals. One is a permanent debarment ordered in January 2023 and withdrawn in July 2023 after an appeals court vacated the convictions.

Special termination (306(d)(4)) is the route open to a person who is permanently debarred. After an informal hearing FDA may shorten the period if the individual gave substantial assistance in investigations or prosecutions. The expired list shows 9 special terminations. The rest of the 61entries are labeled “Expired or terminated”, because FDA's page gives no more detail than that.

FDA stamps each page with “content current as of”. The applications and expired lists carried 2 October 2026 and the imports list 25 September 2026 when this copy was taken on 9 November 2026. FDA's update log dates each change. The latest change to the applications list was 25 September 2026, for Naveed Aslam. The newest order on it takes effect 25 September 2026, and the oldest 8 March 1993.

This copy is rebuilt by a script when FDA changes its pages, not on every request. FDA's website blocks the cloud servers that would run the refresh automatically, so someone runs it by hand. Between refreshes, FDA's page is the record. For a decision that depends on one name, read FDA's current page as well.

• FDA lists names only, with no birth date or address. 3 entries carry FDA footnotes saying the listed person is not the same as another person with the same name. A name match is a reason to read the Federal Register notice, which sets out the conviction and the facts. It does not identify anyone.
• 23 of the 152 applications entries have a citation and no link, all effective before 1995. FDA says Federal Register documents from before 1995 are PDFs on govinfo.gov and that debarments before 1994 are not available online. The citations are copied as FDA prints them.
• Where FDA's row looks mistyped, such as a volume number that does not exist or a date missing a slash, the tool copies the text and adds a note to the row. It does not correct FDA.
• The calculated end date is arithmetic on FDA's effective date and term. Check the order for the date that governs.
• Debarment is one authority. A person can be excluded from federal health care programs or federal contracts without appearing here, and the reverse holds too.

FDA's database of clinical investigator disqualification proceedings is a different action under different rules. It records investigators FDA found to have repeatedly or deliberately failed to comply, or to have submitted false information, and it shows the status of each proceeding (FDA's explanation). The HHS Office of Inspector General keeps the List of Excluded Individuals and Entities for federal health care programs, and SAM.gov lists federal contracting exclusions. We link to these and do not copy them. This tool covers none of the three, and no search of one list shows the standing of a person on another.

The meaning of the debarment list for a sponsor is in the FDA debarment glossary entry: the section 306(k) certification, who it covers, and FDA's 1998 draft guidance, which FDA still links from its list page. Using a debarred person's services can bring civil money penalties under section 307.

FDA offers the current applications list as an Excel file (Single Page Data Format) and publishes no API. The copy behind this tool is public as JSON at arca.inc/data/fda-debarments.json and as a spreadsheet at arca.inc/data/fda-debarments.csv. It holds all three lists, FDA's notations, the later notices and the change log. The scripts that build it and that print every count on this page are in the scripts folder of this site's repository: debarment/build.py and analyze-debarments.py.

What is the FDA debarment list?

FDA's public list of people it has debarred under section 306 of the FD&C Act, which keeps them from providing services to a company with an approved or pending drug application. FDA's list page was current as of 2 October 2026 and shows 152 people, each with an effective date, a term and a Federal Register citation.

What does "are you debarred under the Generic Drug Enforcement Act" mean?

The phrase comes from the certification in section 306(k)(1): an application for approval of a drug product must include a statement that the applicant did not and will not use in any capacity the services of any person debarred under section 306(a) or (b) in connection with the application. The Generic Drug Enforcement Act of 1992 created that section. The statement is the applicant's, about the people whose services it used. FDA's 1998 draft guidance says the wording should not be qualified, with phrases such as "to the best of my knowledge".

How many people does FDA list as debarred?

On the current Drug Product Applications list, 152: 146 mandatory (section 306(a)) and 6 permissive (section 306(b)). The current Drug Imports list has 63, and the expired list 61. FDA's firm tables are empty.

What is the difference between mandatory and permissive debarment?

Mandatory debarment under 306(a) follows a federal felony conviction for conduct relating to the development, approval or regulation of a drug product, and for an individual it is permanent. Permissive debarment under 306(b) is FDA's choice, for a federal misdemeanor, a state felony, or certain felonies such as fraud when the pattern of conduct warrants it. A permissive period is limited to five years per offense, though FDA can run periods consecutively.

Does a debarment ever end?

Yes. A fixed term runs out. A person who is not permanently debarred can apply for termination, FDA must withdraw the order if the conviction is reversed, and an individual can seek a special termination after providing substantial assistance. The expired list holds 61 people.

Is a company ever on the list?

The statute covers firms, with debarment periods of one to ten years for a felony conviction relating to an abbreviated drug application. FDA's firm tables on all three pages say none at the dates shown, so every entry is an individual.

How often is the list updated?

Section 306(e) requires FDA to update its list at least quarterly. FDA's page carries a content-current date and an update log. This copy was taken on 9 November 2026 from pages dated 2 October 2026. A notice published since then is not in it.

Does this tool include disqualified clinical investigators?

No. FDA's clinical investigator disqualification database is a separate action with its own list, linked in the guide. The HHS OIG exclusion list and SAM.gov exclusions are separate as well. None of the three is copied here.

Is there a download?

FDA offers the applications list as an Excel file. The copy behind this tool is public as JSON at arca.inc/data/fda-debarments.json and as a spreadsheet at arca.inc/data/fda-debarments.csv, with all three lists, FDA's notations and the change log.

The search above starts on the Drug Product Applications list. These are the other two lists as FDA prints them, in the same columns.

Drug imports: 63 people, current as of 25 September 2026

Expired or terminated: 61 people, current as of 2 October 2026