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07/18/2014

Owner of McLean skin care clinic sentenced for illegally importing non-FDA-approved drugs for use on patients

Unapproved chemotherapy, cosmetic drugs sold for more than $10 million

ALEXANDRIA, Va. — The owner and operator of Aphrodite Advanced Esthetic & Skin Care Clinic in McLean was sentenced Friday to 18 months in prison and two years of supervised release. The sentence follows an investigation by the Food and Drug Administration's Office of Criminal Investigations, the Drug Enforcement Administration's Group 33 Diversion Task Force, U.S. Immigration and Customs Enforcement's (ICE) Homeland Security Investigations (HSI), the U.S. Postal Inspection Service and the Arlington County Police Department.

On May 6, Anoushirvan Sarraf, 48, of Rockville, Maryland, was convicted of 13 counts related to his involvement in a scheme to illegally import thousands of vials of chemotherapy drugs, injectable cosmetic drugs and devices – none of which were approved by the FDA – into the United States. According to court records and evidence at trial, Sarraf partnered with Gallant Pharma International Inc., an unlicensed wholesale prescription drug distributor headquartered in Arlington, in exchange for a deeply discounted price on non-FDA-approved cosmetic drugs and devices. Over a period of several years, Sarraf used those cosmetic drugs and devices on hundreds of Aphrodite patients without the patients' knowledge or consent.

Sarraf allowed Gallant Pharma to use his medical license to order non-FDA-approved chemotherapy drugs and injectable cosmetics from around the world. Most drugs were shipped first to the United Kingdom, where a trans-shipper would repackage the drugs and send them to the United States in smaller packages addressed to Aphrodite, bearing false customs declarations. When the drugs arrived at Aphrodite, a member of the conspiracy would open the boxes, take what they wanted for Aphrodite and call individuals from Gallant Pharma to retrieve the remaining items. Many of the shipments involved "cold-chain" drugs subject to strict temperature controls, which were not followed by the conspirators. As a result, these drugs posed serious potential harm to chemotherapy and cosmetic patients throughout the United States. For three years, more than 17,000 units of non-FDA-approved pharmaceuticals passed through Aphrodite and were sold by Gallant Pharma for more than $10.33 million.

Ten co-defendants previously pleaded guilty and were sentenced for their involvement in the scheme.

Co-defendant, Eva Montejo Pritchard, 49, of Rockville, who served as Aphrodite's office manager, was also convicted May 6, and will be sentenced July 25.

On July 8, James Quinn, 73, of the United Kingdom, who allegedly served as the trans-shipper for the conspiracy, was arrested in Atlanta, when he attempted to enter the United States. Quinn is expected to make his initial appearance in Alexandria federal court next week.