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Home » PETITION CHALLENGES QSR LANGUAGE IN FORM 483s
PETITION CHALLENGES QSR LANGUAGE IN FORM 483s
April 2, 2004
Larry Pilot, a partner at the Washington, D.C.-based law firm of McKenna, Long & Aldridge, has petitioned the FDA to remove a misleading statement from Form 483s that infers the quality system regulation (QSR) requires devicemakers to identify and correct violations.