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.

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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.

Second Papaya Recall issued as Salmonella Outbreak Grows

One person dead, 35 hospitalized, 109 ill.

A second recall has been issued for Maradol papayas from Mexico as a result of the ongoing investigation into a Salmonella outbreak that has grown to 109 confirmed illnesses.

Agroson’s LLC (Bronx, NY) has recalled 2,483 boxes of Cavi brand Maradol Papayas, grown and packed by Carica de Campeche. The recalled papayas were supplied to wholesalers in New York, Connecticut and New Jersey from July 16 to 19, 2017.

The papayas were available for sale until July 31, 2017. Consumers can identify the papayas by PLU sticker, cavi MEXICO 4395.

According to the recall notice, Agroson’s has ceased importing papayas from Carica de Campeche.

The US Centers for Disease Control and Prevention (CDC) reported earlier today that the Salmonella outbreak linked to consumption of Maradol papayas imported from Mexico has more than doubled in size, and has spread to six additional states.

Most of the increase is due to the addition of cases from a second outbreak strain.

In addition to Salmonella Kiambu, CDC has confirmed a strain of Salmonella Thompson from a sample of papaya is genetically similar to Salmonella Thompson cultures recovered from patients. In all, Salmonella Kiambu has been found in 48 outbreak cases, and Salmonella Thompson in 61.

Confirmed outbreak cases have been reported from 16 states, including: Connecticut (4), Delaware (1), Iowa (2), Kentucky (2), Louisiana (1), Maryland (6), Massachusetts (3), Michigan (1), Minnesota (4), North Carolina (2), New Jersey (26), New York (36), Oklahoma (2), Pennsylvania (7), Virginia (11) and Wisconsin (1).

Texas, which was indicated to have reported a single outbreak cases in CDC’s initial announcement, has been removed from the list of affected states.

The first victim fell ill May 17th; the most illness developed on July 22nd. The youngest outbreak victim was less than one year old; the oldest was 95. Approximately two-thirds of the victims were female, and 68% were of Hispanic ethnicity.

The death was reported from New York City.

Initial investigtions identified Caribeña brand Maradol papayas as a source of the Salmonella Kiambu outbreak. On July 26th, Grande Produce (San Juan, Texas) issued a limited recall of papayas shipped to a Maryland distributor.

Traceback investigations carried out by the US Food and Drug Administration (FDA) have identified the Carica de Campeche farm (Campeche, Mexico) as the likely source of the outbreak. According to FDA, papayas from Carica de Campeche tested positive for Salmonella Agona, Salmonella Senftenberg, and Salmonella Gaminara in addition to the outbreak strains of Salmonella Kiambu and Salmonella Thompson.

As a result of its findings, FDA has added Carica de Campeche to Import Alert 99-35 (Detention without physical examination of fresh produce that appears to have been prepared, packed or held under insanitary conditions) and has removed the farm from the Green List of entities exempt from Import Alert 21-17 (Countrywide Detention Without Physical Examination of Papaya from Mexico).

Carica de Campeche was granted an exemption from this detention notice in 2015.

FDA has stepped up testing of papayas from other farms in Mexico to determine whether they may be contaminated. If Salmonella is found in papaya from a farm, that entity will be added to the Import Alert 99-35 detention list.

What CDC wants consumers to know:

CDC recommends that consumers not eat, restaurants not serve, and retailers not sell Maradol papayas from Mexico until we learn more.

At this time, Caribeña brand papayas from Mexico have been identified as one brand linked to the outbreak.
- Consumers should not eat, restaurants should not serve, and retailers should not sell recalled papayas.
- Additional brands will be announced as the information becomes available.
Maradol papayas have a green skin that turns yellow as the fruit ripens.
A sticker on the Maradol papaya should say if the papaya is Caribeña brand and if it is from Mexico.
If you aren’t sure if the papaya you bought is a Maradol papaya from Mexico, you can ask the place of purchase. Restaurants and retailers can ask their supplier.
When in doubt, don’t eat, sell, or serve them and throw them out.
Wash and sanitize countertops as well as drawers or shelves in refrigerators where papayas were stored.

Contact a healthcare provider if you think you got sick from eating contaminated papaya.

Most people infected with Salmonella develop the following signs and symptoms 12-72 hours after being exposed to the bacteria:
- Diarrhea
- Fever
- Abdominal cramps