FDA 483 - Pharmaloz Manufacturing Inc. - June 21, 2018

Pharmaloz Manufacturing Inc. in Lebanon, PA, a drug manufacturer, was inspected and cited for multiple significant deficiencies. The inspection revealed issues including inadequate investigations into out-of-specification results, poor laboratory data integrity controls (a repeat observation), insufficient employee training, and improper storage conditions for drug products. These findings indicate a moderate level of non-compliance with good manufacturing practices.