FDA WARNING_LETTER - Allure Foods Llc - December 06, 2021

The FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Allure Foods LLC from November 23 to December 6, 2021, to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L. The inspection revealed significant violations concerning imported cashews, roasted/salted fava beans, and natural wasabi peas. The firm failed to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a). Additionally, despite requests, Allure Foods LLC did not promptly provide FSVP records to the FDA, violating 21 CFR 1.510(b)(3). The FDA concluded the firm lacks FSVP records due to inconsistent responses and non-provision of documentation. These deficiencies indicate a failure to ensure imported foods meet U.S. food safety standards. The FDA warns of potential actions, including refusal of admission, detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under section 301(zz) of the FD&C Act. Allure Foods LLC must respond in writing within fifteen working days, detailing corrective actions and providing supporting documentation, such as a copy of their FSVP and implementation records.