FDA 483 - Smithfield Bioscience Inc - July 15, 2022

Smithfield Bioscience Inc. in Cincinnati, OH, received a Form 483 with three observations related to its manufacturing of Heparin Sodium, USP finished API. The inspection revealed significant issues with inadequate investigations into out-of-specification results and environmental excursions, a repeat observation from a previous inspection. Additionally, the firm's environmental monitoring program was found to be unrepresentative of production conditions, and contract testing laboratories were not properly qualified.