FDA 483 - Lohxa, LLC - March 22, 2019

An FDA inspection of Lohxa, LLC, a drug repacker in Worcester, MA, revealed significant deficiencies in its quality systems and manufacturing processes. The firm failed to adequately investigate product complaints, lacked stability data for repackaged products, and did not properly qualify or calibrate equipment. Other critical issues included unvalidated repackaging processes, inadequate cleaning procedures, poor change control, insufficient record retention, incomplete master batch records, and a lack of environmental monitoring justification.