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Bolar former reg affairs director charged

Executive Summary

Jan. 16 criminal information charges Susan Long with one count of causing the submission to FDA investigators of a fabricated R&D raw material report on a lot of triamterene when "there was no such free sample lot of triamterene." A second count charges Long with causing encapsulation records for R&D batches of clindamycin HCl 150 mg, danazol 200 mg, fenoprofen calcium 200 mg and tolmetin sodium 400 mg to be "fabricated and submitted" to investigators "at the direction of an officer of Bolar." The records were given to investigators during an Aug. 21 to Oct. 18, 1989 inspection of Bolar's Copiague, New York facilities. Long is the third Bolar employee to be charged with falsifying product information and obstructing investigations.
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PS018646

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