FDA, where is the Taylor Farms Import Alert?

The FDA’s Import Alert system is an important tool in the agency’s food safety toolbox.

While there are many Import Alerts in effect, covering a range of pharmaceuticals, devices, cosmetics and foods (both human and animal), today’s focus is on Import Alert 99-35: Detention Without Physical Examination Of Fresh Produce That Appears To Have Been Prepared, Packed Or Held Under Insanitary Conditions.

Some context

The FDA gives the following conditions under which a company’s produce may be added to this Import Alert:

Produce is vulnerable to contamination with pathogenic microorganisms if exposed to insanitary conditions during growing, harvesting, packing, holding, manufacturing, processing, or transportation. Multiple foodborne illness outbreaks have been linked to produce that was likely contaminated as a result of insanitary conditions during growing, harvesting, packing, holding, manufacturing, processing, or transportation. Produce is of special concern because in many instances it is consumed without further treatment to adequately destroy or remove pathogenic microorganisms.

FDA may document insanitary conditions that may have resulted in the contamination of produce with human pathogens during an inspection of an establishment that grows, harvests, packs, holds, manufactures, processes, or transports produce. FDA may also use analytical evidence or epidemiological and traceback evidence to establish that produce was grown, harvested, packed, held, manufactured, processed, or transported under insanitary conditions that may have resulted in contamination of the produce with human pathogens.

In order for a company’s produce to be removed from the detention list (known as the Red List), it “…should submit documentation to FDA demonstrating that the firm has resolved the conditions that gave rise to the appearance of adulteration so that the Agency will have confidence that future entries will be in compliance with the Act.”

A recent example

On July 6, 2026, the CDC posted a notice linking a multistate outbreak of 12 cases of E. coli O145 illnesses to GreenWise Organic Frozen Blueberries imported from Chile. The blueberries had been sold in Publix stores in multiple states.

Three days before the CDC went public with the outbreak notice, Frutas y Hortalizas del Sur S.A. (San Carlos, Chile) recalled the implicated batch of blueberries. On July 29, 2026, Publix expanded the company’s initial recall to include all lots of the GreenWise frozen blueberries.

The connection between the product and the outbreak cases was made based on epidemiological and traceback information only. Neither the CDC nor the FDA reported having found the outbreak strain in a sample of the blueberries.

On July 27th and 28th, the FDA added multiple frozen berry products from four Chilean suppliers to Import Alert 99-35. The entities named in the alert were: COMFRUT SA (Santiago, Chile), Comercial Fruticola S.A.(COMFRUT) (Santiago, Chile), Comfrut Curico (Maule, Chile) and Frutas y Hortalizas del Sur S.A. (Nuble, Chile).

Where is the Taylor Farms Import Alert?

Import Alert 99-35 specifies the following criteria, either of which can merit adding a company’s produce to the Red List. It is not necessary for both criteria to be met in order for a company to qualify for inclusion on the list.

Inspectional evidence demonstrating that produce has been grown, harvested, packed, held, manufactured, processed, or transported under insanitary conditions whereby it may have become contaminated with pathogens.
Epidemiological evidence, traceback evidence, and expert opinion.

There are thirteen countries (fourteen, if one includes US-based importers) represented on the Red List. One of the thirteen is Mexico.

There are 26 individual Mexican companies on the Red List, cited for pathogens ranging (alphabetically) from Cyclospora to Shigella.

The produce items listed for detention include papayas, peppers, herbs and spices, berries, and green onions.

Taylor Farms de Mexico is NOT one of those 26 companies. Iceberg lettuce (or any other variety of lettuce) is NOT one of the produce items.

Why is Taylor Farms de Mexico not on the Red List?

It can’t be because the outbreak is too small to be worthy of notice. Even using the CDC’s most recent outbreak notice (released on July 24, 2026), there are at least 1,947 confirmed Cyclospora outbreak cases in nine states, with 98 people hospitalized. In comparison, the outbreak linked to frozen blueberries comprises only 12 cases in two states.

It can’t be because the linkage is “only” based on epidemiological and traceback data. The E. coli O145 outbreak was linked to frozen blueberries based on the same level of data.

It can’t be because there hasn’t been enough time to add Taylor Farms de Mexico to the Red List. The two outbreaks have overlapping timelines.

In 2013, this company’s lettuce was linked to an outbreak of Cyclospora. It is evident that the investigation into the root cause of that 2013 outbreak was unsuccessful or incomplete. Otherwise, the same problem would not have reoccurred.

Taylor Farms de Mexico qualifies to be added to the Red List through epidemioloigical and traceback evidence linking its produce to a foodborne disease outbreak. It is also a repeat offender. A two-time loser.

The bottom line

The Import Alert system is designed to place the onus on foreign suppliers with a history of food-safety problems to prove their produce is safe BEFORE it is allowed into distribution in the United States.

Taylor Farms de Mexico has a troubled food-safety history and deserves to be added to the Red List for Import Alert 99-35 pronto.

TAINTED formats 3 — “Reads like a true crime novel” – Food Safety News

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Chapter 6. Birth of a Pathogen

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Nara’s German manufacturer fails FDA inspection- Correction

Milchwerke “Mittelelbe” GmbH, the German manufacturer of Nara Organic’s Whole Milk Infant Formula, has been added to the FDA’s Import Alert 40-05 list after an inspection of the production facility found “serious deviations of the Infant Formula Requirements per 21 CFR Part 106.”

Import Alert 40-05 provides specifically for “Detention Without Physical Examination Of Adulterated And Misbranded Infant Formula.”

The entry for Milchwerke “Mittelelbe” GmbH, dated 06/26/2026, states that “…the firm’s powdered infant formula products processed in the facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, in that they were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health.”

The Import Alert cited the lack of a flow diversion valve on the pasteurization system, failure to take corrective action following the detection of Cronobacter sakazakii in a “high-hygiene” zone of the processing facility, inadequate environmental monitoring for Cronobacter sakazakii, failure to maintain the plant in a clean and sanitary condition, and lapses in good personal hygiene practices.

Perhaps the most troubling of these observations is the lack of a flow diversion valve. This valve is designed to monitor the temperature of the milk at the outflow from the holding tube immediately after pasteurization and to divert the milk back into the tank if the temperature at the outflow point is below the required level. The absence of an proper flow diversion valve could result in underpasteurized milk being introduced into the spray-drying process and, thus, into the infant formula powder.

Coming a close second is the inadequate follow-up on detection of Cronobacter sakazakii in the production environment. After finding the pathogen and conducting a “root cause” analysis to determine the source of the contamination, the company failed to take “appropriate and timely” corrective measures.

The abbreviated inspection report summary included in the Import Alert notification also mentioned “cracked and pitted concrete floors, broken and missing tiles, and damaged grout” in areas where the infant formula is processed.

According to the website ImportGenius, which tracks US Customs activities, Nara Organics took deliver of a total of nine shipments of infant formula between July 29, 2025 and April 30, 2026. (Thank you to one of my loyal readers for this information. Please note the corrected paragraph, below.)

To be clear, the Nara Organics powdered infant formula batches implicated in the infant botulism outbreak currently under investigation were manufactured by Milchwerke “Mittelelbe” GmbH. However, an unspecified number of the shipments were manufactured using organic whole milk powder produced and processed by the same US supplier that produced the whole milk powder used in ByHeart’s organic infant formula powder.

The picture painted by the FDA’s Import Alert is very different from Nara’s rosy description of a “state-of-the-art” facility.

According to the FDA’s updated Outbreak Investigation report, the agency is in the process of reviewing corrective responses submitted by Milchwerke “Mittelelbe” GmbH, and also has been in contact with relevant European authorities.

Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations?

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Chapter 6. Birth of a Pathogen

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Outbreaks in Quebec, Twin Cities Traced to Chinese Raspberries

Frozen raspberries imported from China were the source of 615 confirmed cases of norovirus in Quebec between March and July of this year, and of 15 cases in Minnesota in August of 2016.

The Quebec outbreak included clients and staff at seven seniors’ residences, two daycare centers and one hotel in four separate administrative regions of the province, according to a spokesperson for Quebec’s Ministry of Health and Social Services (MSSS).

Confirmed cases were documented in Mauricie at 6 seniors’ residences, in Laurentides at a conference at a hotel, in Chaudieres-Appalaches at a daycare center, and in Capitale-Nationale at a daycare center and a seniors’ residence.

Of the 615 outbreak victims, 141 were employees of at least two of the seniors’ residences. Four were employees at one of the affected daycare centers. Citing privacy concerns, MSSS declined to provide any further details on the victims by gender, age or geographic location. However, extrapolation of data provided by the provincial health agency suggests about 250 of the outbreak victims were seniors, and 33 were children.

The Minnesota outbreak was linked to ice cream manufactured by Sebastian Joe’s, a Minneapolis-based company, according to a spokesperson from the Minnesota Department of Health (MNDOH). The company supplied the ice cream to multiple venues within the Minneapolis-St. Paul area.

Norovirus illnesses were linked to consumption of raspberry chocolate chip flavor ice cream consumed at two Sebastian Joe’s venues, one private gathering, and one area restaurant. Of the 15 confirmed cases, 10 were female. One person was hospitalized.

The ice cream contained frozen raspberries imported from China. Analyses conducted by the Food and Drug Administration confirmed the presence of norovirus matching the case specimens in samples of the raspberries.

The Twin Cities and Quebec outbreaks occurred more than six months apart and appear to have been independent of each other, though frozen raspberries from China were implicated in both. Taian Runko, the company identified by the FDA during its analytical sampling, was not involved in the Quebec outbreak, according to the CFIA.

Product recalls lacked transparency
The Canadian Food Inspection Agency (CFIA) issued 14 recall notices, from June 20 through Aug. 21 this year. The agency disseminated 11 of the recalls only to businesses in the food industry, with no public warning released. Recall notices dated Aug. 11, 16 and 21 were released to the public, and alluded to the existence of “…reported illnesses associated with the consumption…” of the recalled products.

From June 23 through Aug. 14, Quebec’s Ministry of Agriculture, Fisheries and Food (MAPAQ) issued a series of six public alerts and product recalls, which included numerous bakery products manufactured with the individually quick frozen (IQF) raspberries. Each of the MAPAQ alerts warned of “many” illnesses associated with the consumption of products containing the IQF raspberries.

The U.S. Food and Drug Administration carried out analytical sampling and laboratory analysis when advised of the Minnesota outbreak, according to an agency spokesperson. As a result of the FDA investigation, the agency added IQF raspberries from Taian Runko Industry International Trade Co. Ltd. to the Import Alert 99-35 “Detention Without Physical Examination” list (Red List) on May 2 this year. Sebastian Joe’s initiated a product withdrawal as a result of the 2016 Minnesota outbreak.

Canadian health agency never issued alert
The Public Health Agency of Canada (PHAC) never issued a public health alert in conjunction with the IQF-raspberry norovirus outbreak. A spokesperson for PHAC explained the agency’s silence was because of the outbreak having been confined to a single province.

In Quebec, the provincial health department responsible for investigating the 5-month outbreak did not issue any news releases or public health alerts either. According to a MSSS spokesperson, food recalls are the responsibility of MAPAQ and CFIA. The spokesperson added that MSSS worked in collaboration with MAPAQ and other federal authorities on the investigation.

The first public notice of the Quebec outbreak was contained in a public warning and recall notice issued by MAPAQ on June 23. The CFIA did not include a similar warning with its recall notices until Aug. 11.

No public health alerts were posted on the Minnesota Department of Health website regarding the norovirus illnesses or ice cream recall in that state.

What consumers should know about norovirus
Norovirus is the leading cause of outbreaks from contaminated food in the United States, according to the Centers for Disease Control and Prevention. It accounts for approximately about half of all foodborne illnesses in the country every year.

Symptoms of norovirus infection include nausea, vomiting, diarrhea and stomach pain. The symptoms usually develop within 12 to 24 hours after exposure to the virus and last one to three days days.

Although extremely unpleasant, most cases of Norovirus are self-limiting, and do not present a long-term health risk, according to the CDC. Nevertheless, seniors and young children are at heightened risk of severe dehydration if infected with the virus.

Most cases of norovirus illness in the population at large are shrugged off as so-called stomach flu. Victims are usually not seen by doctors, and the infections go unreported.

A national survey carried out in the United Kingdom in 2011 determined that only one in every 23 people with norovirus consulted a physician. Overall, for every 288 cases of norovirus occurring in the general population, only one was reported to national surveillance authorities.

Timeline for Quebec, Minnesota outbreaks
August 4-14, 2016: Norovirus illnesses associated with consumption of raspberry chocolate chip ice cream at four Minneapolis-St. Paul area venues.

March-May 2017: Three separate outbreak clusters involving six seniors’ residences, all of which were serviced by a single central kitchen.

May 2, 2017: Individually quick frozen (IQF) Red Raspberries from Taian Runko Industry International Trade Co. Ltd. in Taian, Shandong China, is added to the Red List of Import Alert 99-35, citing norovirus GII contamination.

May 31, 2017: CFIA is notified by Quebec authorities that norovirus outbreak clusters appear to be linked to raspberries, and initiates a food safety investigation.

June 2017: Two additional outbreak clusters occur, one at a daycare center and the other at a hotel.

June 20, 2017: CFIA issues first product recall notice for IQF raspberries imported from China.

June 23, 2017: MAPAQ issues first consumer alert and recall notice for IQF raspberries and some products containing the raspberries, reporting for the first time the existence of “many” illnesses associated with consumption of IQF raspberries.

July 2017: Two additional outbreak clusters are reported, one at a daycare center and the other at a seniors’ residence.

This story first appeared in Food Safety News and is reproduced here with permission.