483
AstraZeneca Pharmaceuticals LPAstraZeneca Pharmaceuticals LP – FDA 483, May 31, 2024
Record Details
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.
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ID · 4a1a7d2c-db13-49cb-bab9-3235ea58515f
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