FDA 483 - AstraZeneca Pharmaceuticals LP - May 31, 2024

AstraZeneca Pharmaceuticals LP in Gaithersburg, MD, was inspected regarding its corporate headquarters operations. The inspection revealed significant deficiencies in quality control, laboratory record-keeping, and complaint handling for its Beyfortus/Nirseveimab pre-filled syringes. Issues included inadequate investigations into manufacturing discrepancies, incomplete data for product quality and sterility, and insufficient oversight of third-party manufacturers and batch release.