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  5. Bernardo Farms, LLC - 686727 - 09/25/2024
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WARNING LETTER

Bernardo Farms, LLC MARCS-CMS 686727 —

Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Lordson Jim Valenzuela Bernardo, Co-owner
Recipient Title
Jimmy Valenzuela Bernardo, Jr., Co-owner
Bernardo Farms, LLC

15-3120 Pahoa Kapoho Rd
Pahoa, HI 96778
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States

WARNING LETTER
CMS 686727

Dear Messrs. Bernardo:

The U.S. Food and Drug Administration (FDA) inspected your farm located at 15-3120 Pahoa Kapoho Rd., Pahoa, HI 96778 from April 21, 2024, through April 25, 2024. 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 papayas 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 provide personnel with adequate, readily accessible toilet facilities, including toilet facilities readily accessible to growing areas during harvesting activities, as required by 21 CFR 112.129(a). Specifically, while at the papaya growing area, FDA investigators did not observe any toilet facilities. Additionally, you stated that the harvest area did not have a toilet facility and that you and your employees urinate outside of the field, in the “windbreak" area (adjacent to the field) and wash hands before returning to work. If they need to use a plumbed toilet, employees are instructed to drive to a public restroom (approximately 3-4 miles away) or drive to an employee’s home (approximately 1 mile from the field).

During the inspection, you stated that you would have a toilet facility in place within 30 days. We will evaluate the adequacy of your corrective action at the next inspection.

2. You did not store and maintain equipment and tools to protect covered produce from being contaminated with known or reasonably foreseeable hazards and to prevent the equipment and tools from attracting and harboring pests, as required by 21 CFR 112.123(b)(2).

Specifically, harvest bags and papaya picking tools, both of which contact the papayas, were observed in direct contact with the cargo bed of a truck which is used to transport garbage. The truck bed had accumulated soil and contained empty drink bottles and at least one cigarette stub.

Further, papayas were observed in direct contact with a board wrapped in frayed bubble wrap that had accumulated dirt on the packing table. You indicated this board was designed to separate different sizes of papayas on the packing table. The papayas contact this surface after manual, visual sorting, and prior to being packaged.

During the inspection, you stated that you would receive plastic liners for the truck bed. We will evaluate the adequacy of that corrective action at the next inspection.

3. You did not establish and keep documentation of the date and method of cleaning and sanitizing of equipment subject to Subpart L used in covered harvesting, packing, or holding activities, as required by 21 CFR 112.140(b)(2).

On April 21, 2024, when asked to provide records related to the cleaning and sanitizing of equipment and tools, such as harvest/picking bags, picking tool, plastic dish tubs, packing table cover, reusable gloves, and harvest bins, you stated you do not keep records documenting any cleaning and/or sanitizing. This observation was also discussed with you during the February 20-21, 2023 FDA inspection of your farm.

On April 25, 2024, you provided a Cleaning and Sanitation Record for the cleaning conducted on April 21, 2024, and indicated that you will continue to document your cleaning and sanitization of tools and equipment. The continuation of these corrective actions will be verified during a future inspection.

4. You did not establish and keep records that document required training of personnel, including the date of training, topics covered and persons trained, as required by 21 CFR 112.30(b).

Specifically, on April 21, 2024, when asked to provide training records for your (b)(4) employees who handle papayas during covered activities, you stated that you provide training routinely but do not keep a record of training. This observation was also discussed with you during the February 20-21, 2023, FDA inspection of your farm.

On April 25, 2024, you stated you conducted a re-training for employees on April 21, 2024, and had documented the training. The continuation of these corrective actions will be verified during a future 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 action 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: W. Martin Rennells, 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 Mr. Rennells at (240) 402-8415 or at producefarminspection@fda.hhs.gov.

Sincerely,
/S/

Ann Oxenham, Director
Office of Compliance
Center for Food Safety and Applied Nutrition
U.S. Food and Drug Administration

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