WARNING LETTER
Calavo Growers, Inc.
MARCS-CMS 687785 —
October 25, 2024
Delivery Method:
Overnight Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Chantal Vos
Recipient Title
Director of Hawaii Operations
Calavo Growers, Inc.
16-747 Milo St
Keaau
,
HI
96749
United States
Issuing Office:
Human Foods Program
United States
October 25, 2024
WARNING LETTER
CMS 687785
Dear Ms. Vos:
The U.S. Food and Drug Administration (FDA) conducted a domestic investigation at your papaya packing and holding operation, located at
(b)(4)
, on April 16, 2024. We understand that you contract with farms that grow and harvest papayas for you. During the investigation, you told our investigator that you provide your contracted growers and harvesters with papaya seeds, agricultural water, harvest bins, food safety training, written food safety plans, food safety recordkeeping templates, and toilet and hand-washing facilities. Based on conversations with you during this investigation and your contracted growers and harvesters, we understand that you have committed to not only provide all of your contracted growers and harvesters with adequate, readily accessible toilet facilities, but also to provide the supplies and maintenance for those facilities.
From April 20, 2024 to April 22, 2024, FDA inspected
(b)(4)
, your contracted grower and harvester, located at
(b)(4)
. At the conclusion of this inspection, FDA investigators issued
(b)(4)
a Form FDA 4056, Produce Farm Inspection Observations. This inspection revealed serious violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, Title 21, Code of Federal Regulations, Part 112 (21 CFR Part 112) (Produce Safety regulation).
Based on the 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 were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered farm to comply with the Produce Safety regulation is prohibited by Section 301(vv) of the Act [21 U.S.C. § 331(vv)]. Even though you contract with other farms to grow and harvest the papayas that you pack and hold, you have an obligation to know how growing and harvesting activities are being performed so that your farm can make decisions to ensure fulfillment of all relevant duties applicable under the Produce Safety regulation [see 80 Fed. Reg. 74354, 74420 (Nov. 27, 2015)]. You may find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov.
The significant violations of the Produce Safety regulation are as follows:
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, from April 20, 2024 to April 22, 2024, during an inspection at the
(b)(4)
farm, located at
(b)(4)
, FDA investigators observed inaccessibile toilets. During this inspection,
(b)(4)
stated that the toilet facility, located approximately 0.30 miles away from the
(b)(4)
location, was too far. He also stated that harvest employees urinate in the bush area adjacent to the papaya field because the toilets are too far away.
(b)(4)
noted that the toilet facility is provided and maintained by the packer (
(b)(4)
). On April 22, 2024,
(b)(4)
was issued an FDA 4056, Produce Farm Inspection Observations.
This was a repeat observation from the 2023 inspection at this farm.
During the 2024 investigation at
(b)(4)
, representatives acknowledged the violations and your farm’s responsibility for them by verbally committing to move certain toilet facilities closer to some growers and to order 4-5 additional composting toilets to keep at all locations, including for the tracts of land where young papaya trees are not yet producing harvestable fruit. The same representatives also stated that they would work on a plan for disposing of the compost waste. Your 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 firm 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 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. Your written response should be sent to Joel Merriman, Compliance Officer, at joel.merriman@fda.hhs.gov.
Sincerely,
/S/
Maria S. Knirk, J.D.
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
Content current as of:
12/03/2024
Regulated Product(s)
Food & Beverages