www.fdanews.com/articles/190345-massachusetts-devicemaker-cited-for-discrepancy-investigation-reports
Massachusetts Devicemaker Cited for Discrepancy Investigation Reports
February 25, 2019
The FDA cited Acorda Therapeutics’ Chelsea, Massachusetts manufacturing facility for its handling of discrepancy investigations.
The facility’s quality unit had multiple discrepancy investigations from 2016 to 2018 that exceeded their one-month closure target dates.
The discrepancies included ones for environmental monitoring and a facility investigation, as well as a deviation and calibration out of tolerance discrepancy.
