483
BSP Pharmaceuticals SpABSP Pharmaceuticals SpA – FDA 483, Mar 23, 2022
Record Details
An FDA inspection of BSP Pharmaceuticals S.p.A., a drug product manufacturer, revealed significant deficiencies in manufacturing process controls, complaint handling, equipment qualification, and electronic data integrity. The firm failed to establish adequate control procedures for media fills, properly investigate customer complaints, qualify equipment for its intended use, and ensure the accuracy and control of electronic data from computerized systems.
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ID · 3c1888ce-6dae-4af7-9cc7-89243028fb7e
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