FDA 483 - Atlanta Supersource, Inc. - July 19, 2024

During an inspection conducted from July 15-19, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Atlanta Supersource, Inc., a manufacturer of hand sanitizer drug products. The document detailed eleven significant observations indicating departures from current Good Manufacturing Practices (GMP).Key issues included a widespread absence of fundamental quality controls. The company failed to validate critical manufacturing processes for its Instant Hand Sanitizer products and utilized non-dedicated equipment without validated cleaning procedures or proper documentation. Laboratory controls were deficient, lacking written test methods, specifications for manufacturing water, and adequate testing of finished products for microbial contamination, identity, and strength of active ingredients like Benzalkonium Chloride. Furthermore, the company relied solely on supplier certificates of analysis without independent verification of raw materials and lacked a stability testing program to establish expiration dates for its products.Documentation failures were also prominent, with incomplete batch production records, including the use of expired raw materials and missing critical information such as actual yields and component details. Distribution records similarly lacked essential lot numbers and shipment dates. The quality control unit demonstrated a critical lack of written standard operating procedures (SOPs) for essential functions like supplier qualification, complaint handling, and investigations. Employee training in GMP was absent, and the firm failed to retain reserve samples of active ingredients.These observations highlight systemic issues across Atlanta Supersource, Inc.'s operations, indicating a critical need for comprehensive corrective actions to ensure product quality, safety, and compliance with federal regulations.