FDA EIR - Zile Bonbons Ag - August 31, 2017

An FDA inspection of Zile Bonbons AG, a contractor manufacturer of dietary supplement oral lozenges located in Rupperswil, Switzerland, was conducted on August 30-31, 2017. This initial inspection focused on the firm's manufacturing, holding, and distributing operations for dietary supplements, specifically referencing CPGM 7321.008A for Dietary Supplements. The primary observation noted on an FDA 483 was the company's failure to establish and maintain written procedures for its quality control operations. This violation, outlined under 21 CFR 111.140(b)(1), highlighted the absence of documented guidelines for critical quality control responsibilities, including material review, disposition decisions, and the approval or rejection of reprocessing activities. Despite performing quality control functions, the lack of formal written procedures was deemed a significant deficiency. During the inspection, an additional concern was raised regarding open containers of unused manufactured product waste on the production floor, which could attract pests. The firm's CEO, Mr. Marc Lehnert, was advised that these observations could constitute violations of the Food, Drug, and Cosmetic Act. Zile Bonbons AG is required to address these conditions voluntarily and provide a written response to the FDA 483 within 15 business days, outlining their planned and implemented corrective actions to ensure regulatory compliance.