FDA 483 - Zile Bonbons Ag - August 31, 2017

Zile Bonbons Ag, a dietary supplement manufacturer in Rupperswil, Switzerland, was cited for a significant quality system deficiency during an FDA inspection. The firm failed to establish and maintain written procedures for its quality control operations, specifically for oral lozenges intended for export to the United States. This lack of essential documentation indicates a serious lapse in ensuring product quality and compliance.