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

Source: https://www.keypedia.com/records/warning_letter/wailea-agricultural-group-inc/285fafef-1980-4a52-8d92-b1f7ab041089

> FDA WARNING_LETTER for Wailea Agricultural Group, Inc on January 17, 2025. Product: N/A. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Wailea Agricultural Group, Inc
- Inspection Date: 2025-01-17
- Office Name: Human Foods Program
- Summary: 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

## Related Officers

- [Laura Akowuah](https://www.keypedia.com/people/laura-akowuah/e0691b01-91e9-4cce-83af-318ca3bd99c6)

Company: https://www.keypedia.com/companies/wailea-agricultural-group-inc/686f02ce-771c-4caa-b8dd-f9d06cfd1ea9

Office: https://www.keypedia.com/offices/human-foods-program/8bff4a0b-7bed-449c-b67b-56a83c96a324