483
Smithfield Bioscience IncSmithfield Bioscience Inc – FDA 483, Oct 27, 2016
Record Details
Celsus Laboratories Inc. in Cincinnati, OH, received a Form 483 citing significant deficiencies in laboratory computer system validation, electronic data oversight, and testing procedures. The inspection also found issues with document control for production batch records, indicating a lack of robust quality unit controls. These observations highlight concerns regarding data integrity and adherence to established manufacturing practices for an API manufacturer.
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ID · 526e561f-ce17-421d-9327-52d8c6ce2b8a
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