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WARNING LETTER

Fresh Express Inc - Div of Chiquita Brands MARCS-CMS 609899 —


Delivery Method:
VIA UPS
Product:
Food & Beverages

Recipient:
Recipient Name
John P. Olivo
Recipient Title
President
Fresh Express Inc - Div of Chiquita Brands

4757 The Grove Drive
Windermere, FL 34786-8426
United States

Issuing Office:
Office of Human and Animal Food Operations East -VI

United States


WARNING LETTER
FY21-HAFE6-WL-01

October 20, 2020

Dear Mr. Olivo:

The U.S. Food and Drug Administration (FDA ) inspected your bagged salad operation located at 1109 East Lake Street, Streamwood, IL 60107, from June 25, 2020 through July 23, 2020. The inspection was initiated as part of an investigation of a multistate foodborne outbreak of cyclosporiasis (human infections with the parasite Cyclospora cayetanensis). As of September 23, 2020, the Centers for Disease Control and Prevention (CDC) reported that at least 701 people from 14 states have been infected with Cyclospora cayetanensis. Based on epidemiological and traceback evidence, CDC and FDA have determined that bagged salad mixes containing iceberg lettuce, carrots, and red cabbage manufactured at your Streamwood, IL facility were the source of this multistate cyclosporiasis outbreak. On June 19, 2020, you recalled bagged salad mix containing iceberg lettuce, red cabbage, and carrots, because they had the potential to be contaminated with Cyclospora. The Public Health Agency of Canada is also investigating an outbreak of cyclosporiasis infections occurring in three Canadian provinces in which Fresh Express brand salad products containing iceberg lettuce, carrots, and red cabbage have been identified as the likely source of the outbreak. This is the second outbreak of cyclosporiasis linked to Fresh Express product. In 2018, a multistate foodborne outbreak of cyclosporiasis involving 511 confirmed cases from 15 states was linked to salads sold at a fast food restaurant and manufactured at your Streamwood, IL facility.

The presence of Cyclospora cayetanensis in your bagged salad mixes, as evidenced by the recent foodborne outbreak, causes your bagged salad mixes to be adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(1)] in that they bear or contain an 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, your recalled bagged salad mixes are also adulterated within the meaning of section 402(a)(4) [21 U.S.C § 342(a)(4)] 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 under section 301(a) of the Act [21 U.S.C. § 331(a)].

During our inspection of your facility, FDA also reviewed your compliance with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). At the conclusion of the inspection, the FDA investigators issued your facility a Form FDA 483, “Inspectional Observations.” We received your written response on August 13, 2020, which characterizes your food safety plan and research that your firm engages in related to Cyclospora cayetanensis. After reviewing your written response, and considering the two outbreaks of cyclosporiasis linked to the Fresh Express Streamwood, IL facility, we have additional concerns as described in this letter. You can find the Act and further information about the CGMP & PC rule through internet links in FDA's home page at http://www.fda.gov.

This letter is not intended to be an all-inclusive list of the violations at your operation or in connection with your products. You are responsible for ensuring that your operation operates in compliance with the Act, the CGMP & PC rule, and other applicable laws. You should take prompt action to correct all violations noted in this letter. Failure to promptly correct these violations may result in regulatory action by FDA without further notice, including, without limitation, seizure and injunction.

In addition to the above violations, we have the following comments:

1. You are required by 21 CFR § 117.135(a)(1) 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 your facility will not be adulterated under section 402 of the Act. Further, because your 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), you must implement a supply-chain preventive control which will significantly minimize or prevent contamination with pathogens, including Cyclospora cayetanensis. Your “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 (GAP) and through [your] Approved Supplier Program.” You have written procedures which describe your supplier approval of growers and harvesters and your verification of your 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 your written response dated August 13, 2020, you mention a “Blue-Ribbon Panel to better understand Cyclospora and [you] have used the learning from this group to enhance [your] 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 your response to the 2018 outbreak, you began pre-harvest testing domestic and imported lots of romaine lettuce and butter lettuce and imported lots of iceberg lettuce for Cyclospora cayetanensis. In your written response dated August 13, 2020, you stated that this testing was not performed as part of your verification activities for the control of the hazard of Cyclospora cayetanensis, but rather to better understand the parasite and potential control mechanisms. We note that after you were notified about the 2020 outbreak you began pre-harvest testing of domestic iceberg lettuce and engaged in a limited amount of post-harvest Cyclospora testing for carrots and red cabbage. You provided FDA with your testing results that showed no detection of Cyclospora cayetanensis in any of your 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 your bagged salad mix.2 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 fecal matter may act as a vehicle of transmission for C. cayetanensis infection.

We recommend that you reanalyze your Food Safety Plan to determine whether your 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 which may contribute to Cyclospora contamination in the field. In addition, you should consider seasonal environmental surveillance for Cyclospora to determine potential sources of contamination near growing regions where you source your produce.

2. FDA experienced delays in Fresh Express’ 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 you are a supplier. Additionally, per your request, FDA provided you with a redacted line list from 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 your retail customers, and lot code information available to date.
  • On June 22, 2020, Fresh Express informed FDA of their communications with affected retailers to date, including their request for retailers to recall all implicated product 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 our initial request, FDA received traceback records from Fresh Express.

We encourage 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. Our hope is that improved traceability records on the part of industry will allow the FDA to more quickly and accurately investigate foodborne outbreaks, helping to avoid human illnesses and unnecessary, costly recalls.

Section 743 of the Act, (21 U.S.C. § 379j-31), authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection related costs.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future. You should include in your response documentation including revised procedures, photographs, results of tests you have conducted, and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations. 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 Lauren Crivellone, Compliance Officer, HAFE6. If you have questions regarding this letter, please contact Compliance Officer Crivelllone at (312) 596-4157 or via e-mail at: Lauren.Crivellone@fda.hhs.gov.

Sincerely,
/S/

William R. Weissinger
Program Division Director
Office of Human and Animal Food
Operations East -VI

 

Cc: Jose Zamperlini, General Manager
Fresh Express Incorporated
1109 East Lake Street
Streamwood, IL 60107-4332

______________________________

1 Blue-Ribbon Panel on the Prevention of Foodborne Cyclospora Outbreaks, “Interim Report,” June 5 2019, available from https://www.freshexpress.com/sites/default/files/brp_interim_report_6.5.19-final.2_2.pdf, accessed on 9/21/2020.

2 FDA and CDC Use Technological Advancements to Investigate Multistate Outbreak of Cyclospora Illnesses Linked to Bagged Salads available from https://www.fda.gov/news-events/press-announcements/fda-and-cdc-use-technological-advancements-investigatemultistate-outbreak-cyclospora-illnesses, accessed on 9/22/2020.

 
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