FDA 483 - Smithfield Bioscience Inc - May 15, 2019

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.