FDA WARNING_LETTER - Regino Produce LLC - April 11, 2022

The FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Regino Produce, LLC on April 5 and 11, 2022, following previous inspections in 2018 and 2021. The inspection revealed the firm was not in compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L, specifically for imported Fried RTE Corn Chips, Fresh Raw Serrano Peppers, and Fresh Raw Lettuce. The primary violation identified was the failure to develop, maintain, and follow an FSVP as required by 21 CFR part 1.502(a), with the firm admitting to not having FSVPs for 85 of 88 imported foods. This marks the third FSVP inspection where the firm lacked FSVPs for most products. The firm's response to the Form FDA 483a, requesting more time, was deemed inadequate due to a lack of documentation. The FDA also noted that FSVPs for covered produce like serrano peppers and lettuce must ensure the same public health protection as required by 21 CFR part 112. Regino Produce, LLC must respond within 15 working days with documented corrective actions. Failure to comply could result in refusal of admission for imported food, detention without physical examination (DWPE), and prohibition of importation under sections 801(a)(3) and 301(zz) of the FD&C Act.