FDA 483 - AstraZeneca Pharmaceuticals LP - May 31, 2024

AstraZeneca Pharmaceuticals LP received an FDA Form 483 following an inspection of its Corporate Headquarters in Gaithersburg, MD, conducted from May 20-31, 2024. The inspection revealed significant deficiencies primarily related to quality control, investigation processes, laboratory records, and complaint handling for its drug products, including Beyfortus/Nirseveimab pre-filled syringes. Key issues observed included a failure to thoroughly investigate unexplained discrepancies and batch failures to meet specifications. Specifically, the company did not adequately assess product impact for batches with visual inspection anomalies, such as air bubbles or stopper defects, and accepted third-party manufacturer conclusions without sufficient internal evaluation. Laboratory records were found deficient, lacking complete data for critical manufacturing controls like stopper integrity and visual inspection qualification. The firm was also cited for selective use of data in risk assessments. Furthermore, AstraZeneca's quality control unit failed to provide adequate oversight, releasing drug product batches that exceeded critical defect limits without proper review or scientific justification. Procedures for handling product quality complaints were also inadequate, with insufficient investigation extensions to third-party manufacturers and a lack of systematic defect trending. These observations indicate a need for comprehensive corrective actions to ensure compliance with pharmaceutical manufacturing standards, reinforce quality assurance protocols, and safeguard product quality and patient safety.