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Tigard Woman Sentenced for Failing to Register as a Distributor of Foreign-Sourced Medical Devices

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Department of Justice
District of Oregon 

FOR IMMEDIATE RELEASE
Thursday, October 27, 2022

PORTLAND, Ore.—A Tigard, Oregon woman pleaded guilty and was sentenced today for failing to register with the U.S. Department of Health and Human Services as a distributor of hyaluronic acid injectables she purchased online from Korea.

Yasemin Zafar, 42, was sentenced to 12 months’ probation and a $1,000 fine.

“U.S. consumers rely on the FDA to ensure that their medications and medical devices are safe and effective,” said Acting Special Agent in Charge Robert M. Iwanicki, FDA Office of Criminal Investigations (FDA-OCI) Los Angeles Field Office. “We will continue to investigate and bring to justice those who threaten the health of consumers by evading FDA requirements.”

According to court documents, sometime in 2018, Zafar began selling hyaluronic acid, a medical product used as a filler for cheek augmentation, without registering with the U.S. Department of Health and Human Services as required by federal law. Zafar knew the products she sold were regulated by the U.S. Food and Drug Administration (FDA). Specifically, in September 2018, Zafar sent messages noting that eBay kept removing her products because they required a prescription and she did not know if the products, which came from Korea, were approved by the FDA. Zafar’s actions intentionally circumvented the FDA’s regulatory authority.

On July 12, 2022, Zafar was charged by criminal information with failing to register as a medical device distributor. Today, before her sentencing, Zafar waived indictment and pleaded guilty to the single charge.

This case was investigated by the FDA-OCI. It was prosecuted by the U.S. Attorney’s Office for the District of Oregon.

Topic(s): 
Consumer Protection

Component(s): 
USAO - Oregon

 
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