FDA 483 - Coupler LLC - August 10, 2023

Coupler LLC, a drug repackager in Horsham, PA, was inspected from August 1-10, 2023, and received a Form FDA 483 with six observations. The inspection revealed significant issues with quality control unit procedures, packaging and labeling verification, equipment design and maintenance, line clearance, retained samples, and master production records. These deficiencies led to the distribution of misbranded drug products and a lack of assurance in product quality and control.