As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

Fresh Express Inc – Div of Chiquita Brands

Windermere, FL

Fresh Express Inc. is on notice from the FDA after an inspection at their facility that was initiated due to their link to a multistate foodborne outbreak of cyclosporiasis.

In an Oct. 20 warning letter, the FDA described a June 18 through July 7, 2020, Foreign Supplier Verification Program (FSVP) inspection at Handylee USA Corp.

The FDA’s inspection revealed that the firm was not in compliance with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule and resulted in the issuance of an FDA Form 483. 

The presence of Cyclospora cayetanensis in their bagged salad mixes, as evidenced by the recent foodborne outbreak, causes their bagged salad mixes to be adulterated in that they bear or contain any added poisonous or deleterious substance which may render them injurious to health. Furthermore, because the only known reservoir of Cyclospora cayetanensis is the human gut, the presence of this parasite in food is an indication of direct or indirect contamination with human feces. Accordingly, the firm’s recalled bagged salad mixes are also adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health. The introduction or delivery for introduction into interstate commerce of food that is adulterated is a prohibited act.

In addition to the above violations, the FDA had the following comments:

  1. The firm is required to identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by their facility will not be adulterated. Further, because their facility manufactures fresh-cut salads which do not receive a kill step (i.e., a process that can be expected to adequately reduce the presence of pathogens in most cases), they must implement a supply-chain preventive control which will significantly minimize or prevent contamination with pathogens, including Cyclospora cayetanensis. The firm’s “Food Safety Plan,” dated January 17, 2020, identifies biological hazards such as human pathogens associated with raw produce, including parasites, as significant hazards that require a supply-chain preventive control at the receiving step. It indicates that these hazards, such as Cyclospora in leafy greens, are “best controlled at the grower level using Good Agricultural Practices and through Approved Supplier Program.” They have written procedures which describe their supplier approval of growers and harvesters and their verification of their supply-chain controls, such as food safety record reviews, GFSI third-party audits, second-party audits conducted by Fresh Express, and periodic supplier questionnaires.

In the firm’s written response dated August 13, 2020, they mention a “Blue-Ribbon Panel to better understand Cyclospora and [they] have used the learning from this group to enhance controls of this parasite,” in response to the 2018 Cyclospora outbreak. As described in the Interim Report of the Blue-Ribbon Panel on the Prevention of Foodborne Cyclospora Outbreaks1 (dated June 5, 2019), there is evidence to suggest that harvest crews and environmental contamination can play a critical role in the spread of Cyclospora contamination on a farm. As part of their response to the 2018 outbreak, they began pre-harvest testing domestic and imported lots of romaine lettuce and butter lettuce and imported lots of iceberg lettuce for Cyclospora cayetanensis. In their written response dated August 13, 2020, they stated that this testing was not performed as part of their verification activities for the control of the hazard of Cyclospora cayetanensis, but rather to better understand the parasite and potential control mechanisms. The FDA notes that after they were notified about the 2020 outbreak they began pre-harvest testing of domestic iceberg lettuce and engaged in a limited amount of post-harvest Cyclospora testing for carrots and red cabbage. They provided the FDA with their testing results that showed no detection of Cyclospora cayetanensis in any of their samples. However, human pathogens, like Cyclospora, are not present in high numbers or homogeneously distributed, and it is not uncommon to see many negatives even when contamination has occurred.

During the 2020 Cyclospora outbreak investigation, FDA tested environmental samples and detected the presence of Cyclospora in the surface water of a canal near a farm suspected of being a source of the red cabbage in their bagged salad mix.  Two samples collected to the north and south of where the farm accessed canal water for seepage irrigation were found to be positive for Cyclospora cayetanensis. Given the emerging nature of genetic typing methodologies for this parasite, the FDA has been unable to determine conclusively if the Cyclospora detected in the canal is the cause of this outbreak. However, water and soil contaminated with the fecal matter may act as a vehicle of transmission for C. cayetanensis infection.

The FDA recommends that they reanalyze their Food Safety Plan to determine whether their preventive controls and grower/harvester verification activities are adequate to ensure control of the hazard of Cyclospora cayetanensis, particularly focusing on potential sources and routes human fecal contamination that would allow partially and fully mature oocysts to contaminate produce in the field before and during harvest. This should include additional focus on handwashing as part of the evaluation for harvesting crew audits, as well as sanitation and cleaning practices for portable toilets, worker health and hygiene, harvest practices, and employee foot traffic through fields, all of which may contribute to Cyclospora contamination in the field. In addition, they should consider seasonal environmental surveillance for Cyclospora to determine potential sources of contamination near growing regions where they source their produce.

  1. FDA experienced delays in Fresh Express’s response to requests for documents used in the traceback investigation.
  • On June 19, 2020, the FDA contacted Fresh Express by phone in reference to an ongoing outbreak of human infections with Cyclospora cayetanensis linked to private label products produced by Fresh Express. On that call, FDA asked Fresh Express to voluntarily recall the implicated product and to share pertinent tracing information, including supplier, customer, and production records related to the impacted brands in the specified date range. FDA issued an outbreak advisory on June 19 identifying three retailers for which they are a supplier. Additionally, per their request, FDA provided them with a redacted line list from the CDC. The line list contained the number of clinical cases, states of residence, onset dates, point of service information, reported food exposures, purchase dates for one of their retail customers, and lot code information available to date.
  • On June 22, 2020, Fresh Express informed the FDA of their communications with affected retailers to date, including their request for retailers to recall all implicated products from commerce and remove it from warehouses, distribution centers, and storage rooms.
  • On June 23, 2020, four days after our initial verbal request, FDA followed up via email to repeat our request for records and information to aid in the public health investigation.
  • On June 25, 2020, almost a full week after the FDA’s initial request, FDA received traceback records from Fresh Express.

The FDA encourages Fresh Express to improve its traceability systems and processes, thus improving the speed and accuracy by which the company complies with records and information requests from the Agency in the future. Greater expediency on the part of Fresh Express in providing the requested traceback records might have aided in tracing back to potential sources of contamination sooner. The FDA’s hope is that improved traceability records on the part of the industry will allow the FDA to more quickly and accurately investigate foodborne outbreaks, helping to avoid human illnesses and unnecessary, costly recalls.

The full warning letter can be viewed here.

Bake’N Joy Foods, Inc.

North Andover, MA

A food company in Massachusetts is on notice from the FDA after a “batch of a nut-containing product was ‘dropped’ on top of the end of a non-nut containing product.

Undeclared allergens are a food safety concern and can be a serious threat to public health.

In an Oct. 29 warning letter, the FDA stated that they determine that Bake’N Joy Foods, Inc. did not follow the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.

The significant violations:

The firm did not identify and implement preventive controls to provide assurances that any hazard requiring a preventive control will be significantly minimized or prevented, and the food manufactured, processed packed, or held by their facility will not be adulterated. Specifically, they did not identify and implement food allergen controls at the mixing/depositor step adequate to significantly minimize or prevent the hazard of undeclared allergens from cross-contact as evidenced by their firm’s adding cranberry nut batter to their Cranberry Orange Flavored Muffin Batter.

The full warning letter can be viewed here.

Handylee USA Corp.

Maspeth, NY

An import company in New York is on notice from the FDA for not having FSVPs for a number of imported food products.

In an Oct. 22 warning letter, the FDA described a June 18 through July 7, 2020, Foreign Supplier Verification Program (FSVP) inspection at Handylee USA Corp.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:

  • Canned corn imported from (redacted)
  • Canned mushrooms imported from (redacted)
  • Canned bamboo imported from (redacted)

The full warning letter can be viewed here.

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