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Abbott

This article was originally published in The Gray Sheet

Executive Summary

FDA inspection of Murex' SUDS rapid HIV-1 test manufacturing was not related to the October closure of the Abbott subsidiary's Norcross, Georgia plant, the firm states. Although the firm planned to resume production in November (1"The Gray Sheet" Oct. 23, 2000, p. 24), it has not yet completed an investigation initiated after the test failed to meet internal specifications. An FDA inspection in August revealed QSR violations, including failure to submit information regarding tests affected by high background/false positive problems and failure to clarify steps that will be taken to investigate negative control and leaking bottle problems, according to a Dec. 15 FDA warning letter

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