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BOLAR’s FORMER R&D DIRECTOR FINELLI CHARGED WITH OBSTRUCTING FDA INSPECTION

Executive Summary

Bolar's former director of research and development, Gena Finelli, is charged with obstructing an FDA inspection of the generic company's Copiague, New York facilities in a criminal information filed Oct. 17 in Baltimore federal court. According to an Oct. 17 release, the criminal information "alleges that on or about Sept. 21, 1989, at the direction of an unnamed officer of Bolar, Ms. Finelli instructed laboratory chemists under her supervision to lie to FDA investigators about the existence of notebooks in which the chemists had recorded activities and the results of tests conducted in the Research and Development Laboratory." Filing of a criminal information, rather than an indictment, indicates that Finelli has pleaded guilty, and the U.S. attorney's statement makes clear that the former Bolar employee "has agreed to cooperate with the government in the investigation." Her arraignment is scheduled for Oct. 25 at 4:30 p.m. Further charges against former Bolar employees may be forthcoming. At the end of the summer, Bolar's current management acknowledged that the firm destroyed certain company documents and fabricated others to obstruct a congressional investigation into the firm's unlawful activities ("The Pink Sheet" Aug. 27, p. 5). Documents regarding the manufacture of Bolar's generic version of SmithKline Beecham's Dyazide were destroyed and documents regarding the raw material were fabricated. The firm also provided false information to FDA to support continued marketing of its generic Dyazide following the revelation that the ANDA contained false information ("The Pink Sheet" Jan. 29, p. 5). Against the background of numerous product withdrawals and the allegations of fraudulent activities, Bolar President Robert Shulman and Exec VP Jacob Rivers resigned. Bolar's former Secretary/Treasurer Lawrence Raiseld replaced Shulman as president. The company also terminated the employment of VP-Operations Charles DiCola, and Director of Quality Assurance Arnold Mendell resigned.
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