483
Patheon Italia S.p.A.Patheon Italia S.p.A. – FDA 483, Sep 29, 2023
Record Details
An FDA inspection of Patheon Italia S.p.A., a biological drug manufacturer in Monza, Italy, identified a significant issue with adherence to established warehousing procedures. The firm failed to follow its written SOP for tracking the storage and movement of materials, leading to discrepancies between inventory records and physical stock in dispensing and storage areas. This indicates a breakdown in material control and record-keeping practices.
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ID · 697016d3-1468-40c9-aab9-50d983f73540
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