Chelsea Labs
Executive Summary
Leonard Wydotis has retired as president of the generic drug manufacturer. Chelsea's parent company, Rugby-Darby Group, said that a plan to move the Chelsea president from New York to Monroe, North Carolina, the location of Chelsea's manufacturing headquarters, was the reason behind Wydotis' decision to retire. A search is underway for a replacement. Chelsea has been under FDA scrutiny because of alleged untrue statements and discrepancies in manufacturing records for certain ANDAs. FDA is planning to withdraw ANDAs and downgrade the therapeutic rating for five drugs to therapeutically inequivalent and, reportedly, is reviewing over two dozen of Chelsea's ANDAs for batch record and formulation inconsistencies.