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Executive Summary

HALSEY WITHDRAWAL OF FOUR PENDING ANDAs due to "possible falsification of documents" is the subject of an Oct. 24 letter from Rep. Dingell (D-Mich.) to FDA Acting Commissioner James Benson. Dingell's letter states that his House Oversight Subcommittee "has been advised that Halsey Drug Co., Inc....has withdrawn four pending ANDAs because of records discrepancies and possible falsification of documents." Reportedly, the problems uncovered by FDA inspections of the Brooklyn--based firm involve batch-size problems and reconstructed raw material cards not in conformance with batch sizes. The agency is said to be considering referral of its findings to the Justice Department for prosecution. Dingell asked FDA to "provide the subcommittee with all documents and records referring or relating to the discrepancies and possible falsification at Halsey, and a list of Halsey employees or ex-employees (and their counsel, if any) with knowledge of these matters." FDA is asked to provide the information by Nov. 5. Last year FDA filed a 10-item FD-483 inspection report focusing mainly on Halsey's recordkeeping. Citations included absence of records to account for discrepancies between the actual yield of a batch and the number of capsules in house. FDA's review of five ANDAs resulted in no findings of fraud by the agency, Halsey said. That inspection, conducted from Aug. 23, 1989 to Oct. 11, 1989, was part of FDA's investigation of the 20 largest generic firms following disclosure of the generic drug scandal ("The Pink Sheet" Dec. 11, 1989, p. 7).

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