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.

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

Abbott enters consent decree with FDA

Abbott Nutrition and the US Food and Drug Administration (FDA) have entered into a consent decree that will enable powdered infant formula production to restart at the company’s Sturgis, Michigan facility in as little as two weeks.

Once production has recommenced, the company estimates it will take from six to eight weeks for product to reach store shelves.

Operations at the Sturgis facility were halted in February 2022, after four infants became ill with Cronobacter sakazakii infections. The infants were fed four different Abbott products: Similac Sensitive, Similac Pro-total Comfort, Similac Advance, and Similac PM 60/40.

Two of the infants died.

According to a statement released by the FDA, under the proposed consent decree, Abbott Nutrition will be required to retain an independent expert to review the Sturgis facility’s operations to ensure compliance with the law.

The proposed decreee also includes requirements for testing products, as well as ceasing production, and promptly notifying the FDA should contamination be detected, as well as the implementation of a sanitation plan, environmental monitoring plan and employee training programs.

The proposed consent decree was filed in U.S. District Court for the Western District of Michigan, and is subject to court approval.

“No conclusive evidence”

In its news release, Abbott emphasized that the FDA and CDC investigations found “… no conclusive evidence to link Abbott’s formulas to these infant illnesses.”

The company listed the following findings of the investigations

CDC concluded its investigation with no findings of a link between Abbott formulas and infant illnesses.
Abbott conducts microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella.
All retained product tested by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter sakazakii and/or Salmonella. No Salmonella was found at the Sturgis facility.
The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of the facility and has not been linked to any known infant illness.
Genetic sequencing on the two available samples from ill infants did not match the strains of Cronobactersakazakii found in our plant. Samples from ill infants did not match each other, which means there was no connection between the two cases.
In all four cases, the state, FDA and/or CDC tested samples of the Abbott formula that was used by the child. In all four cases, all unopened containers tested negative.
Open containers from the homes of the infants were also tested in three of the four cases; two of the three tested negative. The one positive was from an open container from the home of the infant, and it tested positive for two different strains of Cronobacter sakazakii, one of which matched the strain that caused the infant’s infection, and the other matched a strain found on a bottle of distilled water in the home used to mix the formula. Again, neither strain matched strains found in our plant.
The infants consumed four different types of our formula made over the course of nearly a year and the illnesses took place over several months in three different states.

What FDA found

During the intensive investiation carried out by twelve-person team, the FDA documented multiple failings at Abbott’s Sturgis facility.

These included,

Cronobacter sakazakii found in multiple locations in “medium and high care areas of powdered infant formula production, including the hinge attachment and bolt heads on the cover of a scoop hopper for a filler line in the packaging room.
FDA found evidence of Cronobacter sakazakii in a dryer.
Review of company’s records indicated two finished product batches had tested positive for Cronobacter sakazakii.
Water dripping onto the floor in the production area from valves.
Standing water in powdered infant formula production areas (a repeat observation that was first made during the FDA’s September 2021 inspection of the facility and which had not yet been corrected).
Review of company’s records showed a history of internal deterioration in spray dryers dating back to September 2018.
Abbott’s complaint investigations on four consumer complaints (three dealing with Cronobacter sakazakii illnesses and one with a Salmonella Newport illness) did not identify the root causes of the illnesses
During an investigation into the death due to Cronobacter sakazakii of an infant who had been fed Similac Pro Total Comfort infant powder formula, the company’s investigation team did not request that retain samples from the implicated batch of product be tested, even though the company’s own Standard Operating Procedure required this to be done.

During a routine inspection of the Sturgis plant carried out in September 2021, the FDA reviewed complaints received by the company in the two years since its previous inspection. These included:

One complaint of a Cronobacter sakazakii illness in an infant fed Similac Pro-Sensitive powdered formula
One death of an infant fed three different production lots of Similac Alimentum
Fifteen complaints of Salmonella infections in infants fed various Similac or Elecare products. Although an unopened finished product sample was obtained from one of the fifteen cases, no microbiological analysis was conducted on the sample.

All of the complaints were closed by the company following internal investigations.

What next for Abbott?

While there is no smoking gun to conclusively link Abbott’s powdered infant formula products with the four Cronobacter sakazakii illnesses and two deaths, circumstantial evidence is strong, despite the company’s protest to the contrary.

All four victims were fed a product manufactured in Abbott’s Sturgis, Michigan facility
The Sturgis facility had numerous, longstanding maintenance issues, some of which (such as cracks in dryer surfaces) would have increased the risk of chronic pockets of contamination in and on production equipment.
Both the company and the FDA recovered Cronobacter sakazakii from environmental swabs during the 2022 investigation.
Abbott had a history of bacterial illness complaints (15 Salmonella, one Cronobacter sakazakii and one unspecified) during the two years immediately prior to the first reported outbreak case.

At least three separate lawsuits have been filed against the company by parents who believe their babies were made ill as a result of having been fed one of the Abbott powdered infant formula products.

As Rachel Maddow of MSNBC would say, “Watch this space.”

Elite chocolate products linked to Israeli Salmonella outbreak

Twenty-one cases of Salmonella infection may be linked to Strauss-Elite chocolate products manufactured in Nof HaGlil’, Israel, according to a report from the Israel Ministry of Health.

Six of the outbreak victims have been hospitalized.

Samples have been collected from 16 of the victims for lab analysis.

The timeline

On April 19, 2022, Strauss notified the Ministry of Health that Salmonella had been detected in the manufacturing area.

In response, the Ministry instructed Strauss to conduct more extensive testing of its finished products, raw materials, and production environment.

No recall was ordered, and there is no indication that either retailers or consumers were alerted to a potential problem at that time.

After finding additional Salmonella-positive samples, Strauss announced a voluntary recall of multiple Elite brand chocolate products on April 25th.

The following day, the Ministry of Health conducted an inspection of the Nof HaGlil’ production facility.

On April 27th, Strauss expanded its recall to include all expiration dates of “…all of the products manufactured by Elite’s chocolate factory, Elite cakes, Elite wafers, cereal energy bars, chocolate-coated energy rice crisps, bubble gums and taffy candies.”

Inspection results

During the course of its inspection, the Ministry of Health found “significant failings in the Company’s protocols and its conduct.”

As a result, the Ministry has suspended the company’s manufacturing certificate for a period of three months, or until all of the failings have been recitfied.

The issues highlighted in the Ministry’s news release include:

Over the last few months, maintenance works have been performed in the factory all the while the chocolate manufacturing actions continued unchanged, without taking into account the potential risks that may influence the manufacturing process and the factory’s quality control.
During the Ministry of Health’s inspection, the Manufacturer disclosed that several weeks before there was an incident of pigeon infestation in the manufacturing area in the factory. The Company stated that the matter was dealt with immediately and that an exterminator was brought in. However, the Company was required to conduct extensive tests to check whether or not the pigeon infestation influenced the safety of the product in any way.
It was found that the factory’s quality assurance staff has been replaced over the course of last year and that furthermore. Furthermore, the factory’s position for director of food safety was left temporarily vacant. These facts are indicative of the fact that the quality assurance and safety array in the factory was lacking.
Upon the Ministry of Health’s inspection, it was found that a client of the factory has filed a complaint that salmonella indicators were higher than the levels permitted for liquid chocolate. However, the complaint was not processed by the factory as required and no tests were performed to determine the presence of salmonella bacteria.
Upon inspection, a significant failing has been detected in the defrosting of the dairy fat component of milk chocolate. It was found that the defrosting process was not executed in accordance with the manufacturer’s defrosting and storage instructions, a failing that may lead to contamination.

No link to Ferrero-Kinder Salmonella outbreak

To date, approximately 300 samples have been tested, and Salmonella has been recovered from thirty of them.

Fourteen of the cultures have been identified as Salmonella enterica S.16:1, v. –. Work is still in progress on the other samples.

This strain is completely different from the monophasic Salmonella Typhimurium cultures recovered from Ferrero-Kinder chocolates and from clinical samples in the multinational outbreak linked to those products.

Advice for consumers

The recalled chocolates were distributed to a number of countries around the world, including Australia, Austria, Canada, France, Germany, Hungary, Italy, Netherlands, New Zealand, Poland, Romania, Spain, United Kingdom and United States.

Discard all Elite chocolate products.
If you have consumed an Elite chocolate product and are experiencing symptoms of Salmonella (diarrhea, fever, cramps and vomiting), consult your healthcare professional.

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