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WARNING LETTER

Wailea Agricultural Group, Inc. MARCS-CMS 705047 —

Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Michael D. Crowell
Recipient Title
Owner
Wailea Agricultural Group, Inc.

29-2070 Kaiwiki Homestead Rd.
Hakalau, HI 96710
United States

Issuing Office:
Human Foods Program

United States

May 6, 2025

WARNING LETTER


CMS # 705047

Dear Mr. Michael D. Crowell:

The U.S. Food and Drug Administration (FDA or we) inspected your farm located at 29-2070 Kaiwiki Homestead Rd., Hakalau, HI 96710 on January 16 and 17, 2025. Our inspection revealed serious violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation (Produce Safety regulation), Title 21, Code of Federal Regulations, Part 112 (21 CFR Part 112). Based on FDA’s inspectional findings, we have determined that your hearts of palm are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health. In addition, failure to comply with the Produce Safety regulation is a prohibited act under section 301(vv) of the Act [21 U.S.C. § 331(vv)]. You can find the Act and FDA’s regulations through links on FDA’s home page at http://www.fda.gov.

The inspection resulted in FDA’s issuance of a Form FDA 4056 (FDA 4056), Produce Farm Inspectional Observations, listing the observations at your farm during our inspection. To date, we have not received a response to the FDA 4056.

During the inspection, FDA investigators observed the following:

1. You did not ensure that there was no detectable Escherichia coli (E. coli) in 100 ml of agricultural water used for contact with food contact surfaces and used for hand washing during or after harvest, as required by 21 CFR 112.44(a). Additionally, when your agricultural water did not meet the microbial quality criterion for the specific purposes as required under 21 CFR 112.44(a), you did not immediately discontinue those uses, as required by 21 CFR 112.45(a).

Specifically, the water your employees used to wash their hands and clean food contact surfaces tested positive for generic E. coli on September 14, 2024 ((b)(4) MPN/(b)(4)mL), October 6, 2024 ((b)(4) MPN/(b)(4)mL), November 10, 2024 ((b)(4) MPN/(b)(4)mL), and January 5, 2025 ((b)(4) MPN/(b)(4)mL). After receiving these results, you did not immediately discontinue the use of this agricultural water. For example, despite receiving results of (b)(4) MPN/(b)(4)mL of generic E.coli on January 6, 2025, showing that your water did not meet the microbial quality criterion under 21 CFR 112.44(a), your farm continued to use this water for washing hands and cleaning and sanitizing activities from January 6-16, 2025, before any corrective action was taken. Additionally, during the inspection, you did not stop the use of this water.

During the inspection, you told our investigator that a (b)(4) water treatment system would be installed within two weeks. We will evaluate the adequacy of your corrective actions during the next inspection.

2. You did not inspect, maintain, and clean, and, when necessary and appropriate, sanitize all food contact surfaces of equipment and tools used in covered activities as frequently as reasonably necessary to protect against contamination of covered produce, as required by 21 CFR 112.123(d)(1).

Specifically, our investigator observed a machete used for harvesting hearts of palm stored on the visibly dirty floor of a gator truck. Prior to asking your harvest employee a series of questions, our investigator observed that employee pick up the machete from the floor of the gator truck and walk towards a palm tree without inspecting or cleaning the tool.

During the inspection, you stated (b)(4). We will evaluate the adequacy of your corrective action during the next inspection.

3. You did not have at least one supervisor or responsible party for your farm successfully complete food safety training, as required by 21 CFR 112.22(c).

Specifically, you stated (b)(4). This requirement was discussed with you during our previous inspection which concluded on February 25, 2020.

During the January 2025 inspection you stated (b)(4). We will evaluate the adequacy of your corrective action during the next inspection.

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your farm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps that you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your reply to the Food and Drug Administration, Attention: CDR Joseph Frost, Compliance Officer, Center for Food Safety and Applied Nutrition, Food and Drug Administration 5001 Campus Drive, College Park, MD 20740, or electronically to producefarminspection@fda.hhs.gov. If you have questions regarding any issues in this letter, please contact CDR Joseph Frost at (240) 402-4651 or at producefarminspection@fda.hhs.gov.

Sincerely,
/S/

Laura Akowuah, JD, MPH
Acting Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
U.S. Food and Drug Administration
 

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