Roal Produce, Inc – FDA Warning Letter, Mar 9, 2021

On July 27, 2021, the FDA issued a Warning Letter to Roal Produce, Inc. following FSVP inspections on February 25, March 3, and March 9, 2021, and previously on October 24-26, 2018. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L, which mandate risk-based activities for imported food to meet U.S. food safety standards.

The FDA found Roal Produce, Inc. non-compliant with 21 CFR part 1 subpart L for all imported foods, including honey, ground pepper, and pumpkin seeds from supplier (b)(4). The primary violation cited was the failure to develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). This deficiency was noted in both the 2018 and 2021 inspections, with Form FDA 483a, FSVP Observations, issued each time.

Roal Produce, Inc.'s March 18, 2021, response, stating an intent to comply and requesting four months to develop FSVPs, was deemed inadequate due to a lack of detail and supporting documentation.

Failure to address these violations may result