Abbott Nutrition: What price profits?

In the calendar year 2021, Abbott Laboratories, the parent company of Abbott Nutrition, spent almost $2.3 BILLION to repurchase shares of its stock.

This was in addition to $403 million spent for the same purpose in 2020, $718 million in 2019, and $238 million in 2018.

In 2020, Abbott Laboratories’ net profits were in excess of $7 BILLION, an increase of more than 57% over the net profits of the year before.

Between September 2019 and January 2022, while the corporation’s profits soared and Abbott Laboratories plowed billions of dollars into a stock buy-back program, maintenance and quality control issues at Abbott Nutrition’s Sturgis plant snowballed.

Early warnings

The early warning signals were evident during the FDA’s 2019 annual inspection of the company’s manufacturing facility, as documented in the Establishment Inspection Report, obtained by eFoodAlert in response to a Freedom of Information Act request.

Between September 2018 and September 2019, both the FDA and the company received several complaints of illnesses among babies who had been fed a Similac infant formula product. These included:

A report from a Pediatric Nurse Practitioner that five babies under the practitioner’s care had suffered from projectile vomiting after consuming Similac Sensitive Infant Formula (multiple batch codes).
An infant diagnosed with Enterobacter (Cronobacter) sakazakii after consuming three different infant formula products, two of which were Similac products. The infant was treated with antibiotics and recovering.
A baby was infected with Salmonella after consuming a specific batch code Similac Total Comfort infant formula.
An infant consumed Similac Sensitive infant formula and developed high temperature and vomiting. The infant was diagnosed with Salmonella.
A male baby tested positive for Salmonella after consuming a batch of Similac Sensitive infant formula.
A baby possibly infected with Salmonella after having been fed two different batches of Similac Sensitive.
A baby being fed Similac Advance formula died. The cause of death was unknown

The company responded to all of these complaints by conducting reviews of its records for similar complaints (none found), reviewing batch records, and the results of microbiological tests conducted at the time of manufacture.

In some cases, the company conducted microbiological tests of retained samples from the indicated batches, with uniformly negative results.

In response to the Cronobacter complaint, Abbott also carried out microbiological testing on the consumer’s opened product, with negative results.

In addition to the consumer complaints, the company’s own lab found Cronobacter in a sample of Alimentum Advance Powder on August 5, 2019, during the course of routine finished-product testing activities.

In response, Abbott quarantined the Cronobacter-positive batch, in addition to the batches produced immediately before and after the contaminated batch.

After investigating the source of the contamination, the firm identified the root cause as being “…due to a non-routine intervention.”

According to the company’s records, the firm identified and implemented corrective actions, and designated the contaminated batch for destruction.

Environmental monitoring results from after the “non-routine intervention” showed two fails followed by two pass results (ie., Cronobacter-negative) on follow-up.

The 2019 FDA inspection

The FDA’s 2018 inspection resulted in the Sturgis facility receiving a clean bill of health. In fact, all of the prior inspections of this location from 2011 through 2018 were without adverse observations, according to the FDA inspection database.

The 2019 Establishment Inspection Report (EIR) describes the FDA visit as a “comprehensive surveillance inspection” which was conducted as part of the Infant Formula Program and Medical Foods Program.

However, even with the history of complaints, the agency conducted only a superficial lab investigation. FDA inspectors obtained samples of two finished products to conduct nutrient analysis and microbiological tests.

Both finished products yielded negative test results for both Cronobacter and Salmonella.

Despite Abbott’s acknowledgment of having found Cronobacter in a finished product and in the environment, the inspection did not included any raw material, in-process, or environmental sampling.

The visual inspection observations included in the EIR indicate a production plant that appeared to be in good repair, with proper attention given to maintenance and sanitation.

There was no evidence of insect or rodent infestation, and no birds flying through the production or warehouse areas.

The inspectors reviewed the company’s maintenance records, and noted repairs to small cracks and pitted areas along the production lines and on the exterior and inside of dryers.

The only significant negative observation was an error in sampling finished product for microbiological testing. A technician was seen to draw only 30 samples from a production lot instead of the 60 samples required under the sampling plan.

The two-year gap

Whether due to the Covid-19 pandemic or to some other reason, there was no annual inspection of Abbott Nutrition’s Sturgis location in 2020.

When the FDA inspectors returned to Sturgis in September 2021, they found a very different situation. At the completion of their five-day inspection, they issued a formal list of Inspectional Observations (FDA Form 483).

Standing water in multiple locations
Processing operator not sanitizing or changing gloves after touching non-food contact surfaces, before going on to touch food contact surfaces
Lack of calibration of flow meters, pressure sensors and a flow sensor on the product line
Inadequate frequency of temperature monitoring for a pasteurizer, even though temperature was identified as a Critical Control Point for the product in question.

The Form 483 leaves multiple questions unanswered:

What consumer complaints were lodged with either the FDA or the company during the two years between inspections?
Did the FDA conduct environmental, raw material, or finished product testing as part of this inspection?
What other observations were noted during the inspection that did not rise to the level of a formal “Inspectional Observation?”
Were the inspectors aware at the time they were on location that the FDA had received a Cronobacter sakazakii illness report linked to an Abbott Nutriton product?

Answers to at least some of these questions should be contained in the full Establishment Inspection Report. eFoodAlert has requested, but has not yet received, a copy of the full report.

Even in the absence of the full report of the September 2021 inspection, it is clear from the contents of the Form 483 issued at the completion of the January-March 2022 inspection that conditions in the Sturgis plant had deteriorated significantly since 2019.

Environmental samples collected near the start of the FDA inspection revealed the presence of Cronobacter sakazakii in multiple locations. Whole genome sequencing determined that five different strains of the pathogen were present in the plant environment.
Between the end of the September 2019 inspection and February 20, 2022, Abbott’s own testing activities documented at least eight instances of Cronobacter contamination in the environment and two instances of Cronobacter in finished products.
A review of Work Orders revealed multiple instances of water leaks, including one location that was the source of three separate leaks over the course of a year.
A total of 310 “water events” documented by the company between January 1, 2020 and February 1, 2022, including water leaks, moisture and condensation in dry powdered infant formula production areas. These events were not associated with routine clean-in-place equipment cycles.
A history of internal deterioration of dryers dating back to September 2018, including multiple instances of pits and cracks inside the main chambers of at least two dryers.
Inadequate follow-up of consumer complaints received by FDA beginning in September 2021 regarding Cronobacter sakazakii and Salmonella illnesses potentially associated with three different Similac dry infant formula products.

How was this allowed to happen?

Both Abbott Nutrition and the FDA have a lot to answer for.

Ever since a baby died from a Cronobacter sakazakii infection in Tennessee in 2001, the FDA has repeatedly claimed that ensuring the safety of infant formulas was a high priority for the agency.

Yet, the agency allowed two years to elapse between inspections of Abbott Nutrition’s more than sixty-year-old production facility in Sturgis, Michigan.

This lapse, however, does not excuse Abbott’s lack of care.

Food manufacturers–especially those that serve vulnerable populations such as infants–are legally, morally, and ethically bound to ensure the safety of all of their products.

There is no excuse for Abbott’s having abrogated its responsibilities to its customers. Certainly, the company cannot plead poverty as a reason for having neglected to properly maintain its production equipment and manufacturing environment.

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

Recalls and Alerts: March 22-23, 2022

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.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please submit your request using the sidebar link.

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 UPDATE: FDA reports the number of confirmed outbreak cases of Salmonella Saintpaul has risen to 60. Traceback investigations are underway, but a specific source of the outbreak has not yet been determined.

OUTBREAK INVESTIGATION UPDATE: FDA has released a report of its inspection observations in the investigation of a deadly outbreak of Cronobacter sakazakii associated with powdered infant formula manufactured by Abbott Nutrition.

Allergy Alert: A&C Best Food Trading Inc. recalls Licorice Flavor Olive (~1 lb; Date code 2021/10/15; UPC 588552-331090) due to undeclared sulphites.

Allergy Alert: FSIS issues public health alert over concern that certain ready-to-eat salads containing meat and poultry products may contain undeclared egg, milk, peanut or wheat. Please refer to the FSIS notice for a complete list of affected products.

Food Safety Recall: Farm Fresh Produce LLC recalls TWA AGRICULTURE MIXED MUSHROOMS (14.11 oz pkg; UPC 6957937481850; All dates) due to Listeria monocytogenes contamination.

Food Safety Recall: WiseTrade Corporation recalls Global Fresh Marketing Enoki Mushrooms (200g/7.05oz; Product of Korea; UPC 809728-95012) due to possible Listeria monocytogenes contamination.

Food Safety Alert: New York State Department of Agriculture and Markets warns consumers not to consume unpasteurized raw milk labeled as “Grimshaw Farm Raw A2A2 Milk” from Alex Grimshaw/Patrick H. Grimshaw dba Next Generation Creamery due to Salmonella contamination. The producer is now prohibited from selling raw milk until subsequent sampling indicates that the product is free of harmful bacteria.

Canada

Allergy Alert: Uncle T Food recalls Taisun brand Vegetarian Mushroom Jerky (Hot) (169g; All codes where milk is not declared on the label; UPC 4 710095 805096) due to undeclared milk.

Allergy Alert: Dong Phuong Distributor recalls Dam Sen Dried Seafood brand Garlic Roasted Dried Squid (100g; Expiry date 15/12/2022; UPC 8 936140 790872) due to undeclared sesame.

Food Safety Recall Update: Gourmand traiteur (Des Côtés Gourmands inc., Belœil, QC) recalls multiple soups and sauces packed in glass jars due to a possible food safety hazard. Please refer to the recall notice for a complete list of affected products.

Europe

Allergy Alert (Austria): dm drogerie markt recalls dmBio Marzipan Schoko Eier / Marzipan chocolate eggs (125g; All lot/date codes) due to undeclared hazelnuts, milk and soy.

Allergy Alert (Germany): dm-drogerie markt recalls dmBio Marzipan Schoko Eier / Marzipan chocolate eggs (125g; All lot/date codes) due to undeclared hazelnuts, milk and soy.

Allergy Alert (Spain): AESAN warns that several MRM and Lifestyle Tappers brands of prepared dishes made by MRM 2 SAU may contain undeclared sesame. Please refer to the alert notice for a complete list of affected products.

Food Safety Recall (Belgium): Albert Heijn recalls Conimex Panklare nasi (230g; Lots L1194N41, L1229N41 & L1230N41; Best before 13/07/2022, 17/08/2022 & 18/08/2022, respectively) due to a packaging defect.

Food Safety Recall (France): LEGENDES GOURMANDES recalls Légendes Gourmandes brand Préparation pour soupe asiatique / Asian soup mix (115g; Lots 020, 039, 062; Best before 20/01/2023, 08/02/2023 & 03/03/2023, respectively) due to unspecified foreign matter contamination.

Food Safety Recall (Germany): Netto Marken-Discount Stiftung & Co. KG recalls Satori Bambussprossen in Streifen / Bamboo shoot strips (175g drained weight; Best before 27.07.2024) due to possible danger from broken glass.

Food Safety Recall (Iceland): Mjólkursamsalan recalls Colostrum (500 ml; Best before 31.03.2022) because the shelf life does not meet quality requirements.

Food Safety Recall (Iceland): Thi framleiðsla ehf. recalls Mung spírur, Tofu hvítt, Tofu steikt / Mung sprouts, white tofu and fried tofu (All lot/date codes) because food safety was not guaranteed at the production site.

Food Safety Recall (Luxembourg): Auchan recalls Goldsteig brand Mozzarella schnittfest gerieben / Grated mozzarella (200g; Use by 30/04/2022 & 06/05/2022) due to possible foreign matter (pieces of white plastic) contamination.

Food Safety Recall (Romania): CARREFOUR ROMÂNIA S.A. recalls Carrefour Classic brand Salam cu carne de porc / Pork salami (400g; Lot 100722; Use by 05.04.2022) due to foreign matter (metal) contamination.

Australia and New Zealand

Food Safety Recall (Australia): Westhaven Dairy T/A Tasmania’s Westhaven recalls Tasmania’s Westhaven Haloumi (180g; Best before 04/SEP/2022) due to Listeria monocytogenes contamination.

Food Safety Recall (Australia): Southern Sky Cheese Company Pty Ltd recalls Southern Sky Cheese Company Tasmanian Halloumi (180g; Best before 02/July/2022) due to Listeria monocytogenes contamination.

Abbott’s Cronobacter problem more than two years old

The presence of Cronobacter sakazakii in Abbott Nutrition’s Sturgis, Michigan, production facility dates back to at least September 2019, according to information contained in an Inspection Observation report (FDA Form 483) released today by the US Food and Drug Administration (FDA).

The report details a ten-page long list of observations documented by a team of eleven FDA investigators during an inspection that lasted from January 31, 2022 to March 18, 2022.

The inspection was initiated in response to a series of four complaints of infant illnesses and death following consumption of powdered infant formula manufactured in the Sturgis facility.

Cronobacter sakazakii is an opportunistic pathogen, affecting mainly newborns, and causes neonatal necrotizing enterocolitis and neonatal meningitis. In older infants, children and adults, it can cause sepsis and/or respiratory illness. Symptoms in newborns include fever, rapid heart rate, seizures and other neurological abnormalities.

Product Recall

On February 17, 2022, Abbott initiated a recall of multiple Similac, Alimentum, or EleCare powdered infant formulas. The recall notice includes a link to the company website, where a complete list of recalled products can be found.

The recalled infant formula was distributed nationwide across the United States and also exported to multiple countries around the world, including: Australia, Bahrain, Barbados, Bermuda, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Guam, Guatemala, Hong Kong, India, Indonesia, Israel, Jordan, Kuwait, Lebanon, Malaysia, Mexico, New Zealand, Oman, Peru, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, Sudan, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam ANI South.

What FDA Discovered

During the course of their in-depth inspection, the FDA’s investigation team documented multiple issues of concern, among which were:

Presence of Cronobacter sakazakii on environmental surfaces in the packaging room. The sample was collected while a product was being packaged.
Presence of Cronobacter sakazakii on the floor in the immediate vicinity of a dryer.
Presence of Cronobacter sakazakii in a sample of infant formula tested by the company in September 2019.
Presence of Cronobacter sakazakii in a sample of infant formula tested by the company in June 2020.
Water leaking from a dryer inlet and dripping from the valves onto the floor. Company work order documents indicated prior problems with this same inlet in February 2021, November 2021 and again on January 21, 2022.
Standing water in multiple production areas.
Lack of validation of the dry-out step at the end of the dryer cleaning cycle, resulting in a risk that water would remain inside the dryer at the end of the cleaning cycle.
A history of internal deterioration of the firm’s dryers dating back to 2018, including six instances of cracks and pits in the main chamber of two different dryers and ten cracked braces for one of the dryers.
Inadequate investigation of root causes of the four consumer complaints relating to illness reports received by the FDA. These four complaints were each asssociated with a different Abbott product.
Inadequate attention by employees and contractors to the wearing of necessary protective apparel.

In addition to the evidence of inadequate maintenance and sanitation, the inspection report contains observations appear to directly contradict statements made in Abbott’s Voluntary Recall Notice.

Specifically, Abbott stated that the company “…found evidence of Cronobacter sakazakii in the plant in non-product contact areas.” Yet the FDA recovered the microbe from a scoop hopper used to feed scoops, “…which are placed directly inside infant formula containers and contact product.”

Also, Abbott claimed that, “…retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii.”

But the FDA investigators reported that the company’s Medical Safety and Surveillance team did not request that retain samples be tested for the production lot associated with the infant death as of January 31, 2022 (the day the investigators began their inspection).

A History Lesson

As previously reported, the FDA had conducted twenty-seven prior inspections of Abbott’s production facility since 2008. Twenty-four of the twenty-seven inspections resulted in the company’s operations receiving a clean bill of health.

In 2019, the FDA investigation team noted just one deviation during its routine inspection, observing that the firm collected only thirty samples of a production batch for Salmonella testing instead of the specified sixty samples.

Two years elapsed before the FDA conducted its next inspection. In September 2021, a team of two investigators reviewed the Sturgis plant’s operations over a four-day period. They found standing water in multiple locations, sanitation and product-handling lapses, and inadequate temperature monitoring for a pasteurizer.

The September 2021 inspection was carried out after the FDA had received the first complaint of infant illness associated with an Abbott product. The agency has offered no explanation or reason for the more than four month delay between receipt of the first complaint and initiation of an in-depth investigation of the production facility.

According to the CDC, four infants have been infected by Cronobacter sakazakii after consuming a powdered infant formula manufactured by Abbott Nutrition. All four of the infants were hospitalized and two of them have died.

The CDC has received additional reports of possible Cronobacter infections in infants and is conducting investigations to determine whether these may also be associated with this outbreak.

What Consumers Need to Know

The first symptom of Cronobacter infection in infants (0–1 year old) is usually a fever, accompanied by poor feeding, excessive crying, or very low energy. Some infants may also have seizures. Infants with these symptoms should be seen by a medical provider as soon as possible.
Cronobacter germs can cause a dangerous blood infection (sepsis) or make the linings surrounding the brain and spinal cord swell (meningitis). Infections in infants usually occur in the first days or weeks of life. Infants 2 months of age and younger are most likely to develop meningitis if they are infected with Cronobacter.
Visit the FDA’s consumer advisory page to access a complete list of recalled products.

A Postscript

Cronobacter sakazakii was first associated with meningitis in infants in the 1960s. In 2001, the death of an eleven-day old infant in a neonatal intensive care unit (NICU) of a Tennessee hospital was traced to the use of Portagen powdered infant formula manufactured by Mead Johnson. Cronobacter was recovered from nine of forty-eight infants in the NICU.

Following the Mead Johnson incident, the FDA strengthened its surveillance of infant formula manufacturers and improved its lab methods for detecting Cronobacter sakazakii.