FDA 483 - Englewood Lab, LLC - April 23, 2025

Englewood Lab, Inc. in Totowa, NJ, was inspected by the FDA, revealing significant deficiencies in quality control, process validation, and facility maintenance. The firm failed to adequately test incoming raw materials, lacked proper process validation for drug products, and exhibited poor adherence to quality unit procedures and equipment sanitation. These issues indicate a moderate level of severity, impacting product quality and safety.