FDA Failed Again — But No One’s Talking

Remember that scene in the movie Slum Dog Millionaire when the empty water bottles were refilled with tap water then sealed with super glue? That was just a movie.

Here in the United States a more sinister act has been perpetrated by a North Carolina pre-filled syringe factory.

On Feb. 23, 2009, two employees of a pre-filled syringe manufacture, AM2PAT, Inc,  plead guilty and were sentenced to 54 months imprisonment for misbranding syringes for distribution. The employees are Ravindra Kumar Sharma, age 54, of Richmond, Virginia and Aniruddha Petel, age 43, of Carpentersville, Illinois.

Criminal complaints included mail fraud, submitting false statements to a US government entity, and knowingly sending misbranded medical devices into interstate commerce with the intent to defraud.

Syringes were misbranded as “sterile,” when, in fact, the requisite sterility testing on these products had not been completed prior to their shipment into interstate commerce.

Paperwork had been falsified or fabricated to indicate compliance.

The company, AM2PAT, Inc. is responsible for 200 to 300 medical patients throughout the country who developed bacterial infections after having been injected by the syringes. Serious illness such as spinal meningitis, permanent brain damage and even death have resulted in some cases.

AM2PAT, which also sold products under the name Sierra Pre-Filled, produced syringes of heparin and saline, which are often used on already vulnerable patients during cancer treatments, kidney dialysis and other procedures. Read more here

A Federal Grand Jury returned a ten-count Indictment against both AM2PAT, Inc., and its former President, Dushyant Pate on February 19, 2009. Charges include making materially false statements to the Food and Drug Administration in the company’s 2003 Notification to the Food and Drug Administration of its intent to market syringes pre-filled with heparin.

A statement made on Feb. 25 indicated authorities searching for the Chicago-based company’s CEO Dushyant Patel, who had been indicted the week earlier. They believe he fled to his native India.

Read the entire US Attorneys’ Office Press Release here

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