FDA WARNING_LETTER - Bernardo Farms, LLC - April 25, 2024

The FDA inspected a papaya farm at 15-3120 Pahoa Kapoho Rd., Pahoa, HI, from April 21-25, 2024, revealing serious violations of the Produce Safety regulation (21 CFR Part 112). These violations render the papayas adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions. Failure to comply with the regulation is also a prohibited act under section 301(vv).

Key violations include: 1. **Lack of Adequate Toilet Facilities:** No readily accessible toilet facilities were available in the papaya growing area during harvesting, with employees urinating outside the field and driving miles to public restrooms or homes. This violates 21 CFR 112.129(a). 2. **Improper Equipment Storage:** Harvest bags and picking tools, which contact papayas, were stored in direct contact with a garbage-transporting truck bed containing soil, empty bottles, and cigarette stubs. A packing table board, contacting papayas, was dirty and wrapped in frayed bubble wrap. This violates 21 CFR 112.123(b)(2). 3. **Lack of Cleaning/Sanitizing Records:** No documentation was kept for the date and method of cleaning and sanitizing