FDA 483 - Omega Packaging Corp - November 17, 2022

An FDA inspection of Omega Packaging Corp in Totowa, NJ, a manufacturer of hand sanitizer products, revealed significant deficiencies across multiple systems. The firm failed to establish and document adequate test methods, maintain a reliable stability program, ensure proper laboratory record review, and implement approved quality control procedures. Critical issues also included a lack of data integrity controls, insufficient employee training, unvalidated manufacturing processes and water systems, and unvalidated cleaning procedures for equipment.