FDA WARNING_LETTER - Nature’s Way Farms, LLC - July 11, 2022

On June 30 and July 11, 2022, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Nature’s Way Farms, LLC, following a previous inspection on October 21, 2020. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L.

The FDA found that Nature’s Way Farms, LLC is not in compliance with FSVP requirements, specifically failing to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a) for imported foods, including fresh bell peppers and fresh avocados. The company's response to the FDA 483a, dated July 17, 2022, stating a consultant would develop the FSVP by September 1, 2022, was deemed inadequate due to a lack of supporting documentation.

The letter emphasizes that imported fresh produce, being "covered produce," must comply with 21 CFR part 112 (Standards for Produce Safety). Additionally, the company failed to provide correct importer information (name, email, and UFI/DUNS number) at the time of entry for certain shipments, as required by 21 CFR 1.509(a).

Failure to adequately address these violations may result in refusal of admission of imported food under