FDA WARNING_LETTER - Calavo Growers, Inc. - April 22, 2024

On October 25, 2024, the FDA issued a Warning Letter to Milo St, a papaya packing and holding operation, following an investigation on April 16, 2024, and an inspection of a contracted grower/harvester, (b)(4), from April 20-22, 2024. The inspection of (b)(4) revealed serious violations of the Produce Safety regulation (21 CFR Part 112), specifically 21 CFR 112.129(a), for failing to provide adequate, readily accessible toilet facilities for personnel.

During the inspection, FDA investigators observed inaccessible toilets at the (b)(4) farm, with a toilet facility located approximately 0.30 miles away, leading harvest employees to urinate in nearby bushes. This was a repeat observation from a 2023 inspection. The FDA determined that Milo St's papayas are adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Milo St, as the contracting entity providing seeds, water, bins, training, and facilities, is responsible for ensuring compliance with the Produce Safety regulation, as per 80 Fed. Reg. 74354, 74420.

Milo St representatives verbally committed to moving toilet facilities closer and ordering additional composting toilets, along with