Azile Inc. – FDA EIR, Sep 6, 2017

An FDA surveillance inspection of Azile Inc., located in Rolling Hills Estates, CA, was conducted on September 6, 2017. The inspection, carried out under the Division of Field Programs and Guidance #17-13 and the DWCI FY 17 Work Plan, focused on the company's adherence to the Foreign Supplier Verification Program (FSVP) regulations. The primary objective was to assess compliance regarding imported food products, specifically Leek Powder and Ginger Tea, utilized as raw materials for dietary supplements.

The main issue identified was the company's failure to establish written procedures for approving foreign suppliers. Azile Inc. lacked documented processes to ensure that imported foods were sourced exclusively from approved suppliers, a requirement specified in 21 CFR 1.511(c)(2)(i). These procedures must be based on a thorough evaluation of the supplier's performance and the inherent risks associated with the food products.

Following the inspection, an FDA-483 form was issued to Mr. Volker Wypyszyk, the owner. While the firm provided an on-site audit report for the product manufacturer, the critical written supplier approval procedures were absent. Management indicated that Mr. Wypyszyk had recently completed FSVP training and was in the process of compiling and obtaining all the necessary documentation to rectify the observed non-compliance.