FDA Permanently Debars Dr. Shafa Over Drug Felonies
Published Date: 8/31/2026
Notice
Summary
The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Rahim Shafa (Dr. Shafa) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Dr. Shafa from providing services in any capacity to a person that has an approved or pending drug product application and debarring Dr. Shafa for 20 years from importing or offering for import any drug into the United States. FDA bases this order on the findings that Dr. Shafa was convicted of multiple felonies under Federal law that relate to the regulation of any drug product under the FD&C Act and the importation into the United States of any drug or controlled substance under the FD&C Act. FDA provided notice to Dr. Shafa of the proposed debarment and an opportunity to request a hearing. Dr. Shafa submitted a request for a hearing but failed to file with the Agency information and analyses sufficient to create a basis for a hearing.
Analyzed Economic Effects
3 provisions identified: 0 benefits, 3 costs, 0 mixed.
20-year ban on importing drugs
FDA debarred Rahim Shafa for 20 years from importing or offering for import any drug into the United States, effective August 31, 2026. Under section 301(cc) of the FD&C Act, importing or offering for import any drug by, with the assistance of, or at the direction of Dr. Shafa is a prohibited act during that period.
Permanent ban from drug-application work
The FDA permanently debarred Rahim Shafa from providing services in any capacity to a person that has an approved or pending drug product application, effective August 31, 2026. Any person with an approved or pending drug product application who knowingly uses his services during the debarment period will be subject to civil money penalties under section 307(a)(6) of the FD&C Act, and Dr. Shafa himself may face penalties under section 307(a)(7).
FDA will not accept ANDAs involving him
During his period of debarment the FDA will not accept or review any abbreviated new drug applications (ANDAs) submitted by or with the assistance of Rahim Shafa, effective August 31, 2026. Companies attempting to rely on his assistance for ANDA submissions will be unable to have those applications accepted or reviewed by FDA.
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