Beacon Converters, Inc. – FDA EIR, Sep 13, 2016

A surveillance inspection of Beacon Converters, Inc., a manufacturer of Class II sterilization packaging for the medical device and pharmaceutical industries, was conducted by the FDA from September 9-13, 2016. The inspection, performed under Compliance Program (CP) 7382.845, focused on the Production and Process Controls and Corrective and Preventive Action (CAPA) subsystems, including Medical Device Reporting (Part 803). No formal FDA 483, Inspectional Observations, was issued. However, several verbal observations were made. The firm's Corrective and Preventive Action Procedure (SOP 2A-19) was found to be incomplete, lacking provisions for establishing preventive actions and ensuring the dissemination of quality problem information. Specifically, CAPA #98, concerning foreign matter (hair) found in products, failed to include a preventive action and evidence of personnel training on hairnet usage. Additionally, a non-conforming manufacturing report (Lot # (b)(4)) did not follow the required disposition procedure outlined in SOP 2B-5, as a second inspector failed to review the product. Management acknowledged these discrepancies and committed to updating relevant procedures, such as SOP 5G-14, to address the inspectional findings and ensure CAPA procedures effectively prevent recurrence of quality issues.