ARYZ Trading LLC – FDA Warning Letter, Jul 13, 2022

On June 29th through July 13th, 2022, the FDA conducted an FSVP inspection of ARYZ Trading, LLC, finding significant violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FSVP regulation (21 CFR part 1, subpart L). The company failed to develop, maintain, and follow an FSVP for any imported foods, including not conducting written hazard analyses (21 CFR 1.504), evaluating foreign supplier performance (21 CFR 1.505), or performing foreign supplier verification activities (21 CFR 1.506).

The FDA also noted that imported dried mint and sesame seeds tested positive for Salmonella, and extra virgin olive oil contained pesticide chemical residue, rendering them adulterated under section 402 of the FD&C Act. Furthermore, the foreign suppliers for these products are listed on FDA import alerts (99-19 for Salmonella in sesame seeds and dried mint, and 99-08 for pesticides in processed foods).

ARYZ Trading, LLC did not respond to the Form FDA 483a issued on July 13th, 2022. The FDA requires a written response within fifteen working days detailing corrective actions, including documentation of FSVP implementation. Failure to comply may result in refusal of admission for imported foods under section 801(a)(3) of the