FDA 483 - Euphrates Food, LLC - September 27, 2021

An FDA inspection conducted at Euphrates Foods, LLC dba - Labeeb Alani Inc. from September 7 to September 27, 2021, identified a significant non-compliance. The primary observation was the company's failure to develop a comprehensive Foreign Supplier Verification Program (FSVP) for several imported food products. This issue was explicitly acknowledged by the company, which confirmed the absence of an FSVP for a list of specific foreign suppliers and their respective imported foods between August 2020 and September 2021. Notably, this observation is a repeat finding from a previous FDA inspection conducted between March 11 and March 15, 2021, indicating a persistent lack of compliance. The regulatory framework relevant to this observation is the Foreign Supplier Verification Program (FSVP) rule, which falls under the Federal Food, Drug, and Cosmetic Act, specifically Section 805. This regulation mandates that importers establish programs to verify that foreign suppliers produce food in a manner that provides the same level of public health protection as required under U.S. food safety regulations. To address this observation, Euphrates Foods, LLC is expected to promptly develop and implement a robust FSVP for all imported food products for which one is currently lacking. The company is encouraged to discuss any objections or planned corrective actions with the FDA to ensure full compliance with federal food safety requirements and prevent further repeat observations.