FDA 483 - Advance Pharmaceutical Inc - February 27, 2025

An FDA inspection of Advance Pharmaceutical Inc, an OTC drug manufacturer in Holtsville, NY, revealed significant deficiencies in quality unit oversight and control. Observations included failures to monitor storage temperatures for laboratory reference standards, improper handling and storage of raw materials leading to contamination risks, and inadequate storage of in-process materials in an unsecured area. These issues indicate a lack of adherence to established standards for ensuring product quality and preventing contamination.