483
Procos S.p.A.Procos S.p.A. – FDA 483, Feb 22, 2016
Record Details
During an inspection of Procos S.p.A., a pharmaceutical API manufacturer in Cameri, Italy, the FDA observed significant deficiencies in computerized system controls. The firm failed to maintain data integrity on its Empower-3 system, with audit trails disabled for numerous project folders and unauthorized deletion of HPLC projects. These issues raise concerns about the reliability of data used for product release and stability studies.
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ID · 39e3202b-b59d-45ea-962b-2a7975f98f97
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