FDA WARNING_LETTER - Wailea Agricultural Group, Inc - January 17, 2025

On January 16-17, 2025, the FDA inspected Michael D. Crowell's farm in Hakalau, HI, revealing serious violations of the Produce Safety regulation (21 CFR Part 112). The inspection resulted in a Form FDA 4056, to which no response has been received.

The FDA determined that the farm's hearts of palm are adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions, and failure to comply with the Produce Safety regulation is a prohibited act under 21 U.S.C. § 331(vv).

Specific violations include: 1. **Agricultural Water Quality (21 CFR 112.44(a), 112.45(a)):** The farm failed to ensure no detectable *E. coli* in agricultural water used for handwashing and food contact surfaces. Water tested positive for *E. coli* on multiple dates (Sept 14, Oct 6, Nov 10, 2024, Jan 5, 2025), but its use continued for handwashing and cleaning/sanitizing activities from January 6-16, 2025. A water treatment system installation was promised. 2. **Equipment and Tool Maintenance (21 CFR 1