FDA 483 - AstraZeneca Pharmaceuticals LP - January 19, 2023

AstraZeneca Pharmaceuticals LP in Frederick, MD, a drug substance manufacturer, received a Form 483 with two observations. The inspection revealed issues with computer system controls, specifically alterable date/time stamps on systems used for drug substance testing, and inadequate use of sporicidal agents in ISO 5 classified processing areas due to unsupported contact times. These findings indicate significant concerns regarding data integrity and environmental control.