FDA 483 - Pro-Blending LLC - February 05, 2020

An FDA inspection of Pro-Blending LLC in Linden, NJ, revealed significant deficiencies across its quality system, facilities, laboratory controls, and production processes. The firm lacks a functional quality control unit, proper equipment cleaning procedures, adequate product testing, and stability programs for its drug products, particularly Zinc Oxide 20% Blend. These issues indicate a severe lack of adherence to current Good Manufacturing Practices, posing risks to drug product quality and patient safety.