FDA 483 - Unette Corp - September 11, 2025

Unette Corp, an OTC repackager in Randolph, NJ, received a Form 483 for significant quality control deficiencies. The firm failed to thoroughly investigate a high rejection rate of nearly 30% for leaking product packets, subsequently releasing the affected lot without proper review. Additionally, rejected materials were found improperly identified and segregated in the warehouse, indicating a lack of control over nonconforming products.