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Abbott falls on plant QSR (US quality system regulation) failure

This article was originally published in Clinica

Executive Summary

Shares in Abbott Laboratories dropped by over 9% last week on the release of an FDA report that found that its Lake County, Illinois, diagnostic plant still failed to meet US quality system regulation (QSR) standards. The plant, which produces lab and hospital blood tests among a range of 400 medical products, had been visited in January 2002 (see Clinica No 994, p 15). This followed an FDA consent decree in 1999, in which Abbott was fined $100 million and had a slew of products removed from the market (see Clinica No 883, p 1).

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