October 21, 2001 - Aventis' Roussel-Uclaf fined 33 mln usd by US FDA
Aventis Pharma unit Roussel-Uclaf has been fined 33 mln usd by the US Food and Drug Administration for withholding information concerning the whereabouts of plants manufacturing its Cefaclor antibiotic, legal sources said.
According to the federal prosecutor of Maryland, Thomas DiBaggio, this is the first time that a foreign group has been fined in a case involving a product made outside of the US but sold on that market.
The case involved the manufacture of the Cefaclor antibiotic for treatment of respiratory and urinary tract infections in 1995 and 1996 by Roussel-Uclaf Italian unit Biochimica Opos.
Roussel-Uclaf did not disclose to the FDA that the drug was being manufactured in plants in France and Romania, according to a court statement. Roussel-Uclaf pleaded guilty. The FDA insists on knowing the whereabouts of all pharmaceutical products sold in the US so it can carry out plant inspections.
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