FDA 483 - AstraZeneca Pharmaceuticals LP - September 19, 2023

AstraZeneca Pharmaceuticals LP in Mount Vernon, IN, was inspected by the FDA, resulting in two observations. The inspection revealed deficiencies in following written procedures for in-process controls, specifically regarding tablet weight assessment and handling out-of-specification results. Additionally, laboratory records were found to be deficient due to inadequate control and retention of analytical worksheets.