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Abbott Consent Decree Highlights Industry's Process Validation Woes

This article was originally published in The Silver Sheet

Executive Summary

PROCESS VALIDATION DEFICIENCIES were cited prominently in a recent consent decree between FDA and Abbott Laboratories. The enforcement action underscores the persistent difficulty medical device manufacturers have experienced complying with this area of the quality system regulation. Recent data from FDA indicates that nearly one quarter of firms receiving 483s have process validation problems A new guidance developed by the Global Harmonization Task Force is proving popular with manufacturers, especially in helping decide whether a process should be validated or verified WARNING LETTERS: Biologics IVD firms Calypte, Biopool and Biowhittaker cited for QS reg deficiencies; Vanguard Medical reprocessing operations lack adequate validation, FDA says

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