FDA 483 - Lynch Biologics LLC - July 02, 2024

An FDA inspection of Lynch Biologics LLC, a specification developer in Franklin, TN, took place from June 24, 2024, to July 2, 2024. The inspection identified five significant observations related to the company's quality management system. Main violations included inadequate corrective and preventive action (CAPA) procedures, where prior CAPAs were ineffective and new quality concerns regarding product specifications for rhPDGF-BB and "beta-tricalcium phosphate" (-TCP) were not properly addressed. The firm also demonstrated inadequate design change procedures, failing to verify or validate changes to product specifications and to adequately review supplier changes impacting device functionality. Furthermore, risk analysis processes were deemed insufficient, lacking comprehensive risk assessments and proper documentation of risk reduction activities, particularly concerning component storage conditions. Lynch Biologics LLC also failed to control nonconforming products, specifically -TCP cups affected by out-of-calibration supplier equipment, by not segregating or dispositioning them. Lastly, supplier management procedures were found deficient, exemplified by the incorrect classification of a critical supplier for primary container components. To achieve compliance with regulatory requirements, Lynch Biologics LLC must promptly address these observations by revising and effectively implementing robust procedures for CAPA, design control, risk management, nonconforming product control, and supplier qualification.