483
Smithfield Bioscience IncFDA 483 - Smithfield Bioscience Inc - May 15, 2019
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An FDA inspection of Smithfield Bioscience Inc in Cincinnati, OH, an API manufacturer, revealed a significant failure to conduct investigations into out-of-specification (OOS) results. The firm repeatedly re-analyzed heparin sodium samples and re-cleaned environmental monitoring areas without proper investigation or management approval. These findings indicate serious deficiencies in the firm's quality control and investigation processes.
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ID · 42c41f9d-137a-4525-a326-4548b89e4eea