FDA 483 - Reliable Biopharmaceutical LLC - August 20, 2025

An FDA inspection of Reliable Biopharmaceutical LLC in Overland, MO, identified a significant issue with the firm's process water system. The inspection revealed inadequate maintenance and operation, specifically an apparent water leak, which compromises the suitability of water used in manufacturing nonsterile Active Pharmaceutical Ingredients (API) intended for sterile drug products. This indicates a potential risk to product quality and patient safety.