483
Omega Packaging CorpFDA 483 - Omega Packaging Corp - November 17, 2022
Record Details
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.
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ID · 65cc12f1-a932-46f1-b4ae-a10c0db81db0