FDA工厂检查（英文版）

This document provides guidance to the FDA field staff on a new inspectional process that may be used to assess a medical device manufacturer’s compliance with the Quality System Regulation and related regulations. The new inspectional process is known as the “Quality System Inspection Technique” or “QSIT”. Field investigators may conduct an efficient and effective comprehensive inspection using this guidance material which will help them focus on key elements of a firm’s quality system.