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Dear Mr. Lopez and Ms. Lopez:

The U.S. Food and Drug Administration (FDA), along with the Centers for Disease Control and Prevention (CDC), and state and local partners, have investigated numerous multistate outbreaks of Salmonella involving whole, fresh papayas.  FDA has also tested imported whole, fresh papayas as part of its review of products offered for import into the United States under the Federal Food, Drug, and Cosmetic Act (the Act or the FD&C Act).  Your firm has imported papayas that have been implicated in multistate outbreaks of Salmonella in 2017 and 2019, and test results indicated that specific shipments of papaya your firm offered for import in 2011 and 2017 were contaminated with Salmonella. 

FDA has also conducted a Foreign Supplier Verification Program (FSVP) inspection at your facility on August 12, 2019, located at 735 Drake Street, Bronx, New York 10474-6115 to assess compliance with the requirements of section 805 of the FD&C Act [21 U.S.C. § 384a] and the Foreign Supplier Verification Program (FSVP) implementing regulation in 21 CFR part 1 subpart L.  We acknowledge receipt of your response dated August 23, 2019 concerning our investigator’s observations issued to you at the close of the inspection. We will follow up with our evaluation of your submission and compliance with FSVP requirements at a later date.

Outbreaks and Microbiological Analyses

This Warning Letter summarizes evidence that your firm engaged in a pattern of importing or offering for import adulterated food that presented a threat of serious adverse health consequences or death to humans or animals.  Section 306(b)(1)(C) of the Act [21 U.S.C. § 335a(b)(1)(C)] permits FDA to debar a person (defined to include both natural persons and corporations) from importing an article of food or offering such an article for import into the United States if FDA finds that the person has engaged in a pattern of importing or offering for import adulterated food that presents a threat of serious adverse health consequences or death to humans or animals [FD&C Act Section 306(b)(3)(B) (21 U.S.C. § 335a(b)(3)(B)].  Introduction of adulterated foods into interstate commerce is prohibited under section 301(a) of the Act [21 U.S.C. § 331(a)].

We reviewed the evidence relevant to your firm’s involvement in importing or offering for import papayas that were implicated in multistate outbreaks of Salmonella or that tested positive for Salmonella. That evidence included but was not limited to the following.

1. Your firm imported papayas implicated in a multistate outbreak of Salmonella in 2019. Epidemiologic data as documented by the CDC, combined with traceback information gathered by the FDA, support the conclusion that whole fresh papayas distributed by Agroson’s LLC were the source of this multistate outbreak of Salmonella infections.  A summary of the evidence we used to make this determination is as follows.

As of July 5, 2019, a total of 71 people from 8 states have been infected with outbreak strains of Salmonella Uganda.  Of 26 people interviewed, 20 (77%) reported eating papaya in the week before their illness. CDC states that this proportion is significantly higher than results from a survey of healthy people in which 13% of healthy Hispanics reported eating papayas in the months of January through June in the week before they were interviewed.  CDC included over 100 foods in their National Hypothesis Generating Questionnaire and the only food exposure that was significantly correlated to the outbreak of Salmonella Uganda was papaya. Using the FoodNet Population data, CDC compared the 77% papaya consumption by case patients to papaya consumption reported by healthy individuals generally (including non-Hispanics) in the Northeast region (2%), nationally (3%), as well as the proportion of papaya consumption reported by Hispanics (average 13%) between months of January to June and determined that the probability that papaya exposure was unrelated to this outbreak is extremely low.

FDA conducted a traceback investigation for several case individuals that represented various clusters and were able to keep a good history of the food they ate.  The ill people reported thirteen points of service (POS) as the source or likely source of their whole fresh papaya exposures. The thirteen POS represent five different retail stores.  The five different retail stores were included in the traceback, and records show four of the five retail stores received whole fresh papaya from Agroson’s LLC.  Additionally, Cavi brand papayas were documented as being present at the fifth retail store.  During the outbreak investigation, epidemiologic and traceback analyses of records and information supplied by firms along the distribution chain identified your firm as the supplier and distributor of whole, fresh papayas that were the most likely source of reported cases of salmonellosis.

FDA asked your firm, the exclusive distributor of this brand, to conduct a voluntary recall of Cavi brand papayas.  However, your firm refused to initiate a recall.  In order to protect consumers, FDA contacted your wholesale customers to ensure the fruit was no longer available for sale, had been discarded, or not further processed or frozen, and FDA released a public notice to consumers not to consume, sell or distribute Agroson’s Cavi brand papaya. In response to FDA’s July 5th public notice implicating the Cavi brand papayas in the outbreak, your firm sent a letter to multiple customers stating that FDA’s statements were not factual and should be retracted.  Additionally, your firm posted on its public Facebook page that FDA’s assertion that your papayas are the source of the recent Salmonella illnesses is false. 

2. Your firm imported papayas implicated in a multistate outbreak of Salmonella in 2017 and offered for import papayas that tested positive for Salmonella and matched clinical isolates that were associated with an outbreak cluster.

In June of 2017, FDA, CDC and public health and regulatory officials investigated a multi-state outbreak of Salmonella infections linked to imported papayas from four farms in Mexico. CDC reported a total of 251 people that were infected with the outbreak strains of Salmonella Thompson (144), Kiambu (54), Anatum (20), Agona (12), Gaminara (7), Urbana (7), Newport & Infantis (4), and Senftenberg (3), from 25 states. Seventy-nine ill people were hospitalized, and two deaths were reported.

Epidemiologic, traceback, and laboratory evidence indicated that papayas produced by Carica de Campeche and imported to the United States by multiple entities were the source of Salmonella Kiambu, Thompson, Agona, Senftenberg, and Gaminara illnesses, affecting 220 confirmed cases included in the main outbreak cluster associated with this outbreak. Agroson’s LLC was one of the entities that imported product from Carica de Campeche. Among 169 ill persons with available information, 113 (67%) were of Hispanic ethnicity.  Of 145 people interviewed, 79 (54%) reported eating papayas. This proportion was significantly higher than results of the FoodNet Population Survey, where 22% of healthy Hispanic people reported eating papayas in the summer months in the week before they were interviewed. Isolates originating from papayas from Carica de Campeche were linked to the main outbreak cluster genetically, and this relationship was confirmed by the FDA traceback investigation. Papayas originating from Carica de Campeche were recalled by Agroson’s LLC and two other firms.

Additionally, on August 4, 2017 a papaya shipment that your firm imported from El Zapotanito was sampled, and it was confirmed positive with Salmonella Urbana. The isolate from this sample matched clinical isolates that were associated with an outbreak cluster of (7) seven cases. Although this shipment was refused and did not reach consumers, your firm imported adulterated product. 

3. Your firm offered for import papayas that were contaminated with Salmonella in 2011.

On July 9, 2011 and July 14, 2011 your firm imported two shipments of papaya that were sampled while in import status and were both found positive for Salmonella.  Although these shipments were refused and did not reach consumers, your firm imported adulterated product. 

The above violations are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations.  It is your responsibility to ensure your firm complies with all requirements of federal law.

You should take prompt action to correct the above violations. If you do not promptly correct them, we may take further action.  For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. § 381(a)(3)) to refuse admission of food that you import. If you do not promptly correct the above violations, we may place food that you import on detention without physical examination (DWPE) when you import the products.

Furthermore, based on your pattern of importing or offering for import adulterated food that presented a threat of serious adverse health consequences or death to humans or animals, you and your firm may be subject to future regulatory action, including but not limited to, debarring you for a period of up to five years from importing articles of food or offering such articles for import into the United States.  

You should respond in writing within fifteen (15) working days from your receipt of this letter.  Your response should address the specific things you are doing to correct these violations.  You should include in your response documentation and information that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.

Please send your reply to Food and Drug Administration, Attention: Feryal Ahmad, Compliance Officer, Division of Northeast Imports, 1201 Corbin Street, Elizabeth, NJ 07201.  If you have any questions regarding this letter, you may contact Compliance Officer Feryal Ahmad via email at [email protected].  Please reference CMS # 589558 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.

 
Sincerely,

 /s/
Dawne Hines
Program Division Director
Division of Northeast Imports