FDA 483 - Stephen Gould Corporation - October 10, 2025

During an FDA inspection conducted from October 9-10, 2025, Stephen Gould Corporation, a medical device repackager and relabeler located in Gahanna, OH, received a Form FDA 483 outlining significant observations related to its quality management system. The inspection revealed several deficiencies impacting the firm's compliance with established quality requirements. A primary concern was the inadequacy of process control procedures, specifically for the repackaging of tampons. Issues included insufficient sample sizes for first article approvals, discrepancies between incoming and outgoing product case counts, and a lack of proper documentation and control for "test" run materials. Additionally, the inspection found that procedures for quality audits were not adequately established, with no internal audits completed in the past two years and existing procedures not incorporating FDA requirements. Further observations highlighted deficiencies in management review procedures, noting a complete absence of documented management reviews within the last two years, contrary to the firm's own requirements. Finally, the company's procedures for controlling nonconforming products were deemed inadequate, as production records failed to document the reasons for nonconformances, only the quantity quarantined. Stephen Gould Corporation indicated a commitment to correct all identified observations, which are critical for ensuring adherence to quality system regulations for medical devices.