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Home » How to Ensure QSR-Compliant Equipment Control
How to Ensure QSR-Compliant Equipment Control
December 1, 2021
Production and process control failure is one of the most frequent citations in warning letters issued to devicemakers. According to FDA data, about 30 percent of warning letters citing Quality System Regulation (QSR) problems include production and process control issues; about 18 percent of the citations specifically mentioned 21 CFR §820.70(g), which covers equipment control.