FDA 483 - ChiRhoClin, Inc - November 03, 2022

ChiRhoClin, Inc., a contract testing laboratory in Burtonsville, MD, was cited for significant deficiencies in its quality control and laboratory operations during an FDA inspection. The observations highlight issues with data integrity, inadequate personnel qualifications, insufficient documentation for batch release, and a lack of proper equipment calibration and data backup. These findings indicate a systemic failure to ensure the quality and purity of their drug product, ChiRhoStim (Human Secretin).