FDA 483 - Stephen Gould Corporation - October 10, 2025

An FDA inspection of Stephen Gould Corporation in Gahanna, OH, a medical device repackager and relabeler, identified significant deficiencies in their quality system. The firm failed to adequately establish process control procedures for tampon repackaging, lacked proper procedures for quality audits and management reviews, and had insufficient controls for nonconforming products. These issues indicate a systemic failure to ensure product quality and regulatory compliance.