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Georgia Provider Pleads Guilty to FDA Charges

Atlanta MRS Homecare of Tifton, Ga., its chief executive officer and two of its regional managers pleaded guilty to felony charges that included conspiracy to defraud the Food and Drug Administration and failure to register with the FDA those locations where prescription drug oxygen tanks were transfilled, according to the agency.

Under the federal Food, Drug and Cosmetic Act, facilities that fill prescription drug oxygen tanks or canisters must register with the FDA and are subject to agency inspections. The 20-year-old home medical equipment company pleaded guilty May 2 to failure to register seven of its plants throughout Georgia with the intent to defraud or mislead the FDA. It also pleaded guilty to hiding the transfilling operations from the FDA by submitting false documents and statements to the agency and hiding equipment, FDA officials said.

MRS told HomeCare it had "fully resolved" the issues with the FDA and noted: "The charges to which CEO Tom Riddle and MRS Homecare pleaded guilty in Atlanta last week related to activities of company employees which ended more than five years ago. ... Indeed, for nearly the last four years, all transfilled oxygen containers we have distributed to our patients or customers have been filled by an outside service, which is registered with the Food and Drug Administration and which is regularly inspected by the FDA. We have also agreed not to transfill any more oxygen containers ourselves."

The company emphasized that no one was hurt by the medical-grade oxygen distributed at the time in question.

As part of the plea agreement, the company will pay a criminal fine of $225,000, a civil fine of $153,750 to settle Medicare-related violations and $21,250 in restitution to the FDA for investigation costs. In addition, Riddle faces a maximum sentence of five years and a fine not to exceed $250,000. -S.H.

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