NEOLPHARMA, INC. – FDA 483, Apr 1, 2022

NEOLPHARMA, INC. in Caguas, PR, was inspected by the FDA, revealing significant deficiencies in its quality system. The firm failed to follow its own written production and process control procedures, including issues with deviation reporting, change control, work order management, and good documentation practices. Additionally, several standard operating procedures were found to be deficient, lacking specificity and clear instructions for critical operations and facility management.