FDA 483 - Lynch Biologics LLC - July 02, 2024

Lynch Biologics LLC, a specification developer in Franklin, TN, was cited for significant deficiencies across its quality system. The inspection revealed inadequate procedures for corrective and preventive actions, design changes, and risk analysis, leading to unaddressed quality concerns and unverified product specifications. Additionally, the firm failed to control nonconforming products and properly manage critical suppliers, indicating a broad breakdown in quality management.