FDA 483 - New Life Pharma LLC - February 13, 2026

An FDA inspection of New Life Pharma LLC in Northvale, NJ, revealed critical deficiencies in the manufacturing of sterile drug products. The firm failed to establish adequate controls for preventing microbiological contamination, lacked essential sterility testing, and did not maintain proper process validation or quality control procedures. These findings indicate a severe lack of adherence to Current Good Manufacturing Practices for sterile drug production.