Abbott’s walk of shame

As reported yesterday, Abbott Nutrition has entered into a Consent Decree of Permanent Injunction that spells out the conditions under which the company will be permitted to recommence and continue powdered infant formula production at its Sturgis, Michigan, plant.

Despite the company’s protestations of innocence regarding the outbreak of four cases of Cronobacter sakazakii illnesses–including two deaths–in infants who consumed Abbott’s products, the formal Complaint filed by the US Justice Department sets out very clearly the extent of Abbott’s culpability.

The Complaint

After summarizing the relevant statutes, regulations and rules, the Complaint lists the following supporting evidence, found during the inspections carried out by US Food and Drug Administration (FDA) investigators in September 2021 and January-February 2022.

  • FDA lab analysis found C. sakazakii on several surfaces in the production area, including the cover of a hopper that feeds scoops directly into infant formula containers. The sample was collected at the time a batch of formula was being packaged, and the scoops come into direct contact with product.
  • Abbott’s own environmental samples confirmed the presence of Cronobacter spp. on surfaces in the powdered infant formula production area between September 25, 2019, and February 20, 2022. The company did not perform the necessary test to determine whether or not the bacteria were Cronobacter sakazakii.
  • On January 31, 2022, FDA investigators noted the presence of pooled water on several levels of a multi-story spray dryer tower while the spray dryer was being used to produce a batch of powdered infant formula.
  • Abbott’s own records documented a total of 310 “water events” (leaks and condensation) between January 1, 2020, and February 1, 2022, in dry-production areas for powdered infant formula (e.g. during spray-drying and/or container-filling operations). Several of those leaks are described in the company’s records as necessitating repairs to a roof.
  • Abbott had never validated the dry-out step for their spray dryers to ensure that the interiors of the dryers are completely dry following cleaning.
  • Abbott’s own records documented a history of internal deterioration of the spray dryers dating back to September 2018, including (but not limited to) pits and cracks inside the dryers’ main chambers.
  • Plant personnel working in the infant formula production area did not always wear necessary protective apparel.
  • The company failed to conduct an adequate investigation into the validity of a complaint that showed a possible health hazard existed, and failed to test any retained samples of the suspect production lot for microbiological contamination.
  • At the completion of the September 2021 inspection, the FDA issued an FDA-483 form, listing several deficiencies. Although Abbott promised to take corrective action, the company did not implement sustained corrections or demonstrate ongoing compliance with statutory requirements.

On behalf of the FDA, the US Department of Justice has petitioned the Court to issue a permanent injunction requiring Abbott to “… cease manufacturing, processing, preparing, packing, labeling, holding, and/or distributing any article of food unless and until Defendants bring their manufacturing, processing, preparing, packing, labeling, holding, and distribution operations into compliance with the Act and its implementing regulations to the satisfaction of FDA.”

The request also includes authorization for FDA to inspect the company’s “… place(s) of business and all records relating to the receipt, manufacture, processing, preparing, packing, labeling, holding, and distribution of any article of food to ensure continuing compliance with the terms of the injunction, and that Defendants bear the costs of such inspections, including testing and sampling …” and to award costs to the government, including the cost of the investigation to date.

A short leash

The conditions stipulated in the Consent Decree under which Abbott Nutrition will be allowed to resume and maintain production will keep the company on a very short leash.

Abbott will be required to retain an independent expert or experts to evaluate all of the facilities and processes at the Sturgis, Michigan, location, and conduct an inspection to determine what will be necessary to bring the operation into compliance with FDA regulations. The company will be required to notify FDA of the identity and qualifications of the expert within two days after retaining him or her.

Abbott will need to verify the dry-out procedures and validate its method of testing for moisture in production equipment and processing environments.

A pre-production cleaning, sanitizing and dry-out followed by environmental testing for pathogens will be required.

Before starting production, Abbott will be required to provide FDA with a report from the expert that documents completion of all of the verification and validation activities and the pre-production review.

Once production has started, a qualified individual within Abbott’s quality unit will be required to review the batch record, product test results and environmental monitoring for every production lot prior to distribution of the lot. The responsible individual must certify in writing to FDA that each lot meets all specifications.

The consent decree also specifies the testing that must be conducted, and that production be halted and FDA be notified immediately in the event that any in-process or finished product test detects Cronobacter and/or Salmonella. Production will only resume after Abbott receives written permission from FDA.

Abbott must maintain a record of all sales and distribution of its products and make those records available to FDA immediately upon request.

Additional details include specifics as to the required environmental monitoring, training of personnel, preparation and submission to FDA of a plan for building and/or equipment repair, hiring of an auditor to conduct audit inspections of the production facility, methods and processes.

Under the provisions of the decree, in the event the FDA determines that Abbott has not lived up to its agreement, the agency has the authority to order the company to cease manufacturing, and to take whatever other corrective actions the agency deems necessary for protection of public health.

The foregoing is just a sample of the details contained in the 33-page Consent Decree and the 21-page Complaint. Nor is this the end of the story.

In his blog post this morning, Bill Marler warns that criminal sanctions may be in the offing.

Let’s hope the FDA and the US Department of Justice don’t consider Abbott Nutrition to be “too big to nail.”


Learn more about Cronobacter sakazakii and other foodborne disease outbreaks in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, now available in digital, print and audiobook editions.

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“Reads like a true crime novel” – Food Safety News

Recalls and Alerts: May 12-13, 2022

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Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

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Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations? Click on the TAINTED menu at the top of the page to read or listen to a short excerpt, then follow the buy links to add a digital, print or audio copy to your personal library.

Listen to an excerpt of the new audiobook edition right here

Chapter 6. Birth of a Pathogen

United States

OUTBREAK INVESTIGATION: The CDC has closed its investigation into an outbreak of four cases of Cronobacter sakazakii infections in infants. All four infants were hospitalized, and two of them died. The FDA investigation into the incident, which is linked to consumption of powdered infant formulas manufactured by Abbott Nutrition in Sturgis, Michigan, is on-going.

Allergy Alert: HP Hood LLC recalls Planet Oat Chocolate Peanut Butter Swirl Non-Dairy Frozen Dessert ( 1 pt – 473 ml; Best before 12/17/22; UPC 44100709869) and Planet Oat Chocolate Chip Cookie Dough Non-Dairy Frozen Dessert (1 pt – 473 ml; Best before 12/17/22; UPC 44100709906) due to undeclared peanuts.

Allergy Alert: USDA/FSIS issues public health alert due to concerns that Weis Markets’ ready-to-eat (RTE) General Tso Chicken meals may contain milk. Please refer to the public health alert for a complete list of affected products. The products are no longer available for sale.

Allergy Alert: Mrs Miller’s Homemade Jams recalls Smokey BBQ Bacon Jam and Spicy Chili Bacon Jam (packed in glass jars; Sold 04/01/2019 – 05/09/2022) due to undeclared soy.

Food Safety Recall: Mars Wrigley Confectionery US, LLC recalls specific varieties of SKITTLES® Gummies, STARBURST® Gummies, and LIFE SAVERS® Gummies due to potential foreign matter contamination (very thin metal strand). Please refer to the recall notice for a complete list of affected products.

Food Safety Alert: New York State warns consumers not to consume unpasteurized raw milk from Thomas Miller DBA Miller Dairy Farm due to possible Listeria monocytogenes contamination.

Canada

Allergy Alert: Tree Brewing Co. recalls Tree Brewing Co. brand Golden Larch Grapefruit Radler (473 ml; Packaged 16MAR2022; UPC 6 24524 21543 8) and Tree Brewing Co. brand Season Pass 8-pack (8 x 473 ml; Packaged 15MAR2022; UPC 6 24524 45498 1) due to undeclared sulphites.

Food Safety Recall: Au Quai (Drummondville, QC) recalls HARENG FUMÉ À L’HUILE / Smoked herring in oil (Sold up to 10 May 2022) due to improper packaging that presents a food safety hazard.

Food Safety Recall: Gourmet Laurier inc. (Montréal, QC) recalls multiple cheeses made with raw milk due to the absence of a “raw milk” warning on the labels.

Food Safety Recall: Petits pots et gourmandises (Le Locker Distillerie inc., Sainte-Anne-de-Beaupré, QC) recalls three products packed in glass jars (750 ml; Sold up to 12 May 2022) due to improper packaging that presents a food safety hazard.

Food Safety Recall: Mars Wrigley Canada recalls specific varieties of SKITTLES® Gummies, STARBURST® Gummies and LIFE SAVERS® Gummies due to the potential presence of a very thin metal strand embedded in the gummies or loose in the bag. Please refer to the recall notice for a complete list of affected products.

Europe

OUTBREAK INVESTIGATION UPDATE (Belgium): AFSCA reports 62 cases of Salmonella infections linked to consumption of Kinder chocolate products manufactured by Ferrero in Arlon, Belgium. These cases are part of a multinational outbreak.

Allergy Alert (Belgium): AFSCA recalls Chongqing brand Instant Noodle – Hot & Sour Flavour (110g; All lot codes and Best before dates) due to undeclared milk.

Allergy Alert (Belgium): AFSCA recalls ALL4TRADE – ZINE brand Bulgur grof bruin / Coarse brown bulgur (800g; Best before 10/2022) due to undeclared wheat.

Allergy Alert (Ireland): FSAI warns consumers of undeclared wheat in ALL4TRADE – ZINE brand Coarse brown bulgur (800g; Best before 10/2022)

Allergy Alert (Luxembourg): Food Safety Authority recalls Chongqing brand Instant Noodle – Hot & Sour Flavour (110g; All lot codes and Best before dates) due to undeclared milk.

Allergy Alert (Spain): AESAN recalls ALL4TRADE – ZINE brand Bulgur grof bruin / Coarse brown bulgur (800g; Best before 10/2022) due to undeclared wheat.

Food Safety Recall (Belgium): Belki NV recalls Carrefour (Belki) brand burger de poulet Halal et burger de poulet nature / Halal chicken burger and plain chicken burger (250g; Lots 220505012 & 220502020; Use by 15/5/2022 & 13/5/2022, respectively) due to possible Salmonella contamination.

Food Safety Recall (Belgium): Carrefour recalls Carrefour brand Fromage d’Abbaye / cheese (230g; All Best before dates between 12/05/2022 and 14/05/2022) due to possible Listeria monocytogenes contamination.

Food Safety Recall (France):  L’Aquarium recalls Huitres No. 2 / Oysters (Lot 050522H) due to E. coli contamination.

Food Safety Recall (France): J.C.David recalls J.C.David brand Filets de hareng doux fumé / Smoked sweet herring fillets (200g; Lot 119; Use by 03/06/2022) due to Listeria monocytogenes contamination.

Food Safety Recall (France): J.C.David recalls La Cuisine du Poissonnier brand Filets de hareng doux fumé / Smoked sweet herring fillets (200g; Lot 119; Use by 03/06/2022) due to Listeria monocytogenes contamination.

Food Safety Recall (France): LIDL recalls Baguette Céréales Rustique (250g; All lot codes) due to foreign matter contamination (metal).

Food Safety Recall (France): SCAMARK E.LECLERC recalls NOS REGIONS ONT DU TALENT brand FILETS DE HARENG DOUX DU NORD / Smoked sweet herring fillets (200g; Lot 119; Use by 03/06/2022) due to Listeria monocytogenes contamination.

Food Safety Recall (France): CASINO recalls Franprix brand Duo de billes de chèvre Paprika coeur à la tomate et Graines de pavot coeur à la tapenade / Goat cheese ball stuffed with paprika and tomato and goat cheese ball stuffed with poppy seed tapinade (2-pack / 65g; Lots S22-104 & S22-115; Use by 19/05/2022 & 30/05/2022, respectively) due to possible Listeria monocytogenes contamination.

Food Safety Recall (France): VIABAT recalls VIABAT brand Salade de Pieds de Bovins Emincés / Sliced beef-food salad (Lot 117; Use by dates between 07/06/2022 and 17/06/2022) due to Listeria monocytogenes contamination.

Food Safety Recall (France): GERMLINE recalls GERMLINE brand Déli’mix sprouts (50g; Lot 220509; Use by 21/05/2022) due to Salmonella contamination.

Food Safety Recall (France): E.LECLERC recalls PECHE OCEAN brand MIETTES DE SURIMI – SAVEUR CRABE / Crab-flavour surimi crumbs (180g; Use by 20/06/2022; Hour stamp between 15:00 and 17:00) due to Listeria monocytogenes contamination.

Food Safety Recall (France): E.LECLERC recalls LES CROISES brand DUO DE BILLES CHÈVRE TOMATE/PAPRIKA – TAPENADE/PAVOT / Pair of stuffed goat cheese balls – Tomato/paprika and Poppy seed/tapenade (65g; Use by 18/05/2022, 30/05/2022, 06/06/2022 & 07/06/2022) due to possible Listeria monocytogenes contamination.

Food Safety Recall (France): BESNI FOOD recalls Kerem mini figues séchées / Mini dried figs (250g; Lot 21003123 & 22000191; Use by 29/11/2022 & 31/01/2023, respectively) due to aflatoxin contamination.

Food Safety Recall (Germany): Fleisch- und Wurstwaren Schmalkalden GmbH recalls Wilhelm Brandenburg, Paprikapastete mit Joghurt / Paprika pie with yoghurt (100g; Lot 260422; Best before 17.05.2022) due to foreign matter contamination (metal).

Food Safety Recall (Germany): Villani S.p.A. recalls Salame Cacciatore italiano DOP / Italian salami (150g; Lot 240222; Best before 15.07.2022) due to possible Salmonella and Listeria monocytogenes contamination.

Food Safety Recall (Ireland): Marks & Spencer recalls certain products containing chicken due to possible Salmonella contamination. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall (UK): Cranswick Country Foods recalls multiple cooked chicken products due to potential Salmonella contamination. Please refer to the recall notice for a complete list of affected products.

Australia and New Zealand

Allergy Alert (New Zealand): Golden Coin Ltd recalls The Grid brand Shanghai Style Pan-fried Buns (all batches and dates) due to undeclared soy.

Abbott, Ferrero & Strauss – Oh, My!

Analysis and Op-Ed

Although the names sound as though they belong on the letterhead of a law practice, or of an accounting firm, Abbott Nutrition, Ferrero International, and Strauss Group are three distinct companies, located in North America, Europe, and the Middle East, respectively.

Each of these companies is currently managing multinational product recalls.

And two of the recalls have been associated with outbreaks of foodborne disease.

Strauss – Elite Chocolate

On April 19, 2022, Strauss notified Israel’s Ministry of Health that routine testing had revealed the presence of Salmonella “in the manufacturing area” of the company’s Nof HaGlil’ production facility.

The factory manufactures a range of Elite brand chocolate products, and also supplies chocolate to other food processors.

The Ministry of Health instructed Strauss to conduct more extensive tests on its finished products, raw materials, and production environment.

On April 21, 2022, using a rapid test, Strauss found indications of Salmonella in some raw material.

It took an additional three days to confirm these preliminary positive results, during which time no warning was issued to the public. Nor, as far as we can tell, was any product put on hold.

On April 24, 2022, once the preliminary results had been confirmed, Strauss initiated a recall of multiple Elite chocolate products, explaining that Salmonella had been discovered in the production line at the company’s Nof HaGlil’ manufacturing plant. Samples of chocolate used as an ingredient for other products also tested positive for Salmonella.

On April 25, 2022, Unilever Israel recalled multiple ice cream products that contained chocolate supplied by Strauss.

On April 27, 2022, more than one full week after first reporting the presence of Salmonella in the production plant, Strauss expanded its recall to include all expiration dates of all products manufactured by Elite’s chocolate factory, including Elite cakes, Elite wafers, cereal energy bars, chocolate-coated energy rice crisps, bubble gums and taffy candies.

The company has suspended operations at the manufacturing facility while it conducts and investigation into the cause and source of the contamination and carries out an intensive cleaning and sanitizing of the production area.

In addition to being sold throughout Israel, products manufactured in the Nof HaGlil’ facility were exported to multiple countries, including Australia, Austria, Canada, France, Germany, Hungary, Italy, Netherlands, New Zealand, Poland, Romania, Spain, United Kingdom and United States.

Although Israel’s Ministry of Health has not announced any indications of an outbreak linked to the recalled chocolates, The Jerusalem Post reported that a 10-year-old boy was diagnosed with Salmonella on April 27th after being admitted to hospital with severe dehydration as a result of extensive vomiting and diarrhea.

Ferrero – Kinder chocolate products

On December 15, 2021, Ferrero detected Salmonella on the surface and in residual raw materials samples taken from buttermilk tanks in its Arlon, Belgium manufacturing facility.

The company did not notify the Belgian food safety authority of this finding until early April 2022.

Instead, Ferrero suspended production, destroyed the affected semi-finished product, carried out a deep cleaning of the entire line, and resumed production. Finished product manufactured on the line was released for distribution following negative test results.

Additional samples tested in January 2022 also were positive for Salmonella, including two samples from two buttermilk tanks, recorded on January 11th.

As before, the company suspended production, deep-cleaned the line and gradually resumed production.

On February 17, 2022, the UK reported a cluster of monophasic Salmonella Typhimurium cases to the European Centre for Disease Control (ECDC).

Between January 5th and February 8th, Ferrero had submitted nine Salmonella cultures to an Italian lab for serological and molecular typing.

Four of those cultures were a match for the outbreak strain.

By April 8, 2022, the ECDC had received reports of 150 cases from nine EU countries and the UK.

Most of the cases were in children less than ten years of age, and many of the children were hospitalized.

On April 8th, the Belgian food safety authority withdrew its production authorization for Ferrero’s Arlon manufacturing facility, announcing that it could not rely on the information the company had been providing.

That same day, Ferrero recalled all of the Kinder chocolate products manufactured in the Arlon facility.

As of April 19th, the number of cases had risen to 187 cases in 11 EU countries and the UK.

On April 22, 2022, the company expanded its recall to include additional products.

Abbott Nutrition – Powdered infant formula

It could be argued that Strauss’s delay in recalling its chocolate products was relatively minor and without any significant impact on public health.

It is more difficult to justify a similar argument in the case of Ferrero.

Had the company destroyed the finished products impacted by its buttermilk contamination rather than testing and releasing, a multi-national Salmonella outbreak most likely would have been avoided.

Yet, Ferrero’s actions pale in comparison to the situation at Abbott Nutriton’s Sturgis, Michigan production facility, as alleged in a whistleblower complaint lodged with the FDA last October.

According to the whistleblower, company management has been falsifying records, shortchanging preventative maintenance, skimping on sanitation, and turning a blind eye to microbiological problems in the plant.

While we have only the whisteblower’s word for many of the allegations, some of what he or she has reported has been substantiated in the FDA’s Establishment Inspection Reports from September 2019 and September 2021, and in the Inspectional Observations (FDA Form 483) documented during the January – March 2022 investigation of the Sturgis facility, as described in earlier eFoodAlert posts.

FDA actions vis-a-vis Abbott Nutrition

The apparent ease with which Abbott allegedly pulled the wool over the eyes of FDA inspectors during the 2019 and 2021 inspections is troubling, to say the least.

Even though the inspectors were advised during the September 2021 plant visit of consumer complaints of Salmonella infections associated with Abbott products, they did not carry out any independent environmental sampling during the course of their plant visits. Instead, they relied on the company’s reports of how the complaints were investigated and deemed to be unsubstantiated.

Reports of equipment maintenance also were taken at face value, as were sanitation records.

Coincidentally, while the FDA inspectors were on site at Abbott in September 2021, the agency was alerted to the first of four confirmed reports of Cronobacter sakazakii in an infant who had been fed an Abbott powdered infant formula.

The following month, on October 20, 2021, the whistleblower complaint was submitted to the FDA.

The agency did not get around to interviewing the whistleblower until late December, and the FDA did not begin its in-depth investigation into the operations of Abbott’s Sturgis facility until January 31, 2022.

By then, two additional reports of Cronobacter-infected infants and one report of a Salmonella-infected infant had been lodged with the FDA.

Before the completion of the January – March 2022 Abbott inspection, a fourth Cronobacter-infected infant was identified.

TWO OF THE FOUR CRONOBACTER-INFECTED INFANTS DIED.

What next for food safety?

Had Ferrero been living up to its responsibility to produce safe food, there would have been no outbreak of Salmonella Typhimurium in Europe and the UK.

Had Abbott been living up to its responsibility, the four infants would not have become infected with Cronobacter, and the parents of the two dead babies would have been spared a lifetime of grieving.

Likewise, had the FDA lived up to its responsibilities, Abbott’s behavior might have come to light at least two years ago, and the company would have been brought to heel.

There is no excuse for Ferrero, for Abbott Nutrition, or for the FDA.

It is time for food companies who flout good manufacturing practices and who put consumers at risk to pay for their malfeasance.

And it is past time for the US Congress to take a good, long, hard look at the way in which food safety is overseen in the United States.


Learn more about Salmonella in chocolate and Cronobacter sakazakii in infant formula in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, now available in digital, print and audiobook editions.

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