FDA 483 - Alliance Technologies, LLC - June 14, 2024

Alliance Technologies, LLC, a contract testing laboratory in Monmouth Junction, NJ, received a Form 483 with four observations. The inspection revealed significant deficiencies in quality control unit responsibilities, change control processes for methods and systems, and validation of the LIMS computerized system. Additionally, the firm failed to follow established laboratory procedures for labeling and managing standards and SOPs, indicating a lack of robust quality oversight and data integrity controls.