FDA WARNING_LETTER - Keeler Family Farms - November 16, 2021

On November 16, 2021, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Keeler Family Farms in Deming, NM, prompted by a multi-state Salmonella Oranienburg outbreak linked to whole, fresh onions imported from Chihuahua, Mexico. The inspection revealed the firm was not in compliance with 21 CFR part 1, subpart L, as they lacked FSVPs for any imported foods, including onions from their Mexican suppliers. The firm initiated a voluntary recall of red, yellow, and white onions on October 22, 2021.

The primary violation cited was the failure to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a). Despite a December 14, 2021, response to the FDA 483a stating an FSVP program would be effective by June 15, 2022, and intentions to use "Keeler Family Farms" as the sole FSVP importer, the firm continued importing covered foods like alfalfa hay and fresh hot peppers under various FSVPIs without an FSVP.

The FDA warns that continued non-compliance may lead to refusal of admission for imported food under section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert #99-41, and prohibition