FDA 483 - Lohxa, LLC - August 03, 2023

Ichxa, LLC, a repackager in Worcester, MA, received a Form FDA 483 with seven observations during an inspection from July 17 to August 3, 2023. The inspection revealed significant deficiencies in quality control, including inadequate investigations into deviations and complaints, lack of validated processes, and insufficient record-keeping. Many of these issues, particularly regarding investigations, process controls, and cleaning validation, are repeat observations from previous inspections, indicating persistent and serious non-compliance.