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Change Problems Dominate During First Year of Design Control Enforcement

This article was originally published in The Silver Sheet

Executive Summary

DESIGN CONTROL DEFICIENCIES appear to be trending downward since enforcement of the requirements began in June 1998; well-documented development plans are key to an effective design project, industry reps say WARNING LETTERS: Contract manufacturer of Gliatech's Adcon-L adhesion control gel placed on import detention; Critical Disposables, Inc. cited by FDA for QS reg deficiencies  

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