Abbott’s senior vice president grilled by members of House subcommittee

This story by Coral Beach first appeared at Food Safety News and is reposted here with permission

“We know we let you down.” 

The senior vice president of Abbott Nutrition — the manufacturer of infant formula whose plant closure amid a food safety investigation has left the country in dire straits with parents scrambling to find food for their babies — opened his testimony before a U.S. House panel Wednesday with that admission of guilt.

The day-long hearing before the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce was billed as an investigation into the infant formula shortage and the reasons behind it. 

During the first half of the hearing members of the U.S. House of Representatives grilled top administrators from the Food and Drug Administration about the shortage and the agency’s investigation into Abbott’s Sturgis, MI, manufacturing plant. FDA Commissioner Robert Califf told the panel that the agency could have done a better job managing its investigation. (See our related story for complete coverage.)

The second half of the day was reserved for three executives from the baby food industry with about half of the time devoted to the shortage and the other half focusing solely on Abbott’s food safety status.

Abbott was represented by its senior vice president Christopher Calamari. Two other infant formula manufacturers also had top executives on hand to answer questions: Scott Fitz, vice president of Gerber, and Robert Cleveland, senior vice president of Reckitt. Together the three companies represent about 90 percent of the infant formula market in the United States. Abbott alone has 40 percent of the market.

Members of the House subcommittee questioned all three men about the status of infant formula production with little in the way of solutions offered for resolving the current shortage. All of the companies are working to meet the need with ramped-up production at U.S. plants. They are also working with the federal government to increase imports of infant formula.

As pressing as the need for more infant formula is, the reason behind the shortage received as much time in the spotlight as the shortage itself. If Abbott had not had to close down its Sturgis, MI, plant because of food safety issues there would not be a shortage.

Calamari repeatedly told the House subcommittee that Abbott is doing everything possible to get its plant up and running. It was closed down in mid-February when the company initiated a massive recall. The recall came amid an FDA investigation into links to a cronobacter outbreak that saw at least four babies hospitalized. Two of them died.

Time after time Calamari said that Abbott is “taking steps” to resolve food safety problems and make sure they don’t reoccur. Time after time the House members asked what the company is doing. 

When Committee Chair Rep. Diana DeGette, D-CO, asked the question Calamari gave his generalized answer. DeGettee called him on it, seeking more specifics. The Abbott senior vice president then ticked off a handful of actions including replacing floors, repairing the roof, and changing the way personnel move through the 700,000-square-foot manufacturing plant.

During her closing remarks, the subcommittee chair remarked on the bipartisan outrage about the situation at the Abbott plant. She told Calamari that his answers had been “too vague.”

Highlights from other subcommittee members’ questions about the food safety situation and the answers from Calamari follow.

Rep. H. Morgan Griffith, R-VA
The ranking member of the subcommittee told Calamari that Abbott has more than a problem with its roof and floors. He cited a whistleblower document that reported managers hiding information from top corporate management and said the company has a “culture problem” and asked, “have any heads rolled?”

Calamari responded by saying he didn’t think it was a culture problem and that just last week he visited the Sturgis, MI, plant and met with multiple generations of employees there who are committed to producing safe infant formula.

Rep. Cathy McMorris Rodgers, R-WA
When the representative asked why there were cronobacter bacteria in the production facility Calamari said “it wasn’t in the production area,” adding that it is a naturally occurring bacteria. McMorris Rodgers asked Calamari what Abbott is doing to make sure its food safety issues do not recur he said the company “is committed to preventing future problems.”

Rep. Michael C. Burgess, R-TX
Burgess wanted to know when Abbott management was made aware of the whistleblower document. Calamari said they didn’t know about it until it was made public by Congress in April. He also said he did not want to speak to points made in the document because it is the subject of an ongoing investigation.

Rep. Kathleen M. Rice, D-NY
Rice also asked Calamari about the whistleblower document, wanting to know what measures Abbott has in place for employees to raise food safety concerns. Calamari said there is an “independent” entity within the company that takes and reviews employee concerns and that it was the whistleblower’s choice to not use the system to report concerns. Rice also asked what the company plans to do to make sure employees feel comfortable reporting issues and Calamari said the company would “encourage them to speak up.”

Rep. Janice D. Schakowsky, D-IL
Telling Calamari that she is “livid” about the situation and that the inspection report about the Sturgis, MI, plant is “disgusting,” Schakowsky asked him if he would take personal responsibility; he said “yes.”

Rep. Gary J. Palmer, R-AL
Calamari told Palmer that he was not aware of problems at the plant until FDA inspected it earlier this year. When Palmer asked why problems had not been addressed earlier Calamari said the company is committed to safety.

Rep. Scott H. Peters, D-CA
Peters asked how much of Abbott’s resources go toward food safety and Calamari said “tens of millions of dollars.” Peters then asked if it should be more. Calamari said, “we are committed to doing what it takes.”

Rep. Kim Schrier, D-WA
Schrier wanted to know why Congress should trust Abbott to fix problems at the production plant, especially in light of the whistleblower accusations of falsified records. Calamari said, “we are aligned with the FDA” on plans to reopen the plant.


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

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: February 22-23, 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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United States

OUTBREAK ALERT / Food Safety Recall: Vadilal Industries (USA) Inc. recalls Custard Apple Pulp, frozen (35.27 oz; Batch/Lot codes KWHO, KRQO; Best before September 2023; UPC 8901777282168) due to potential Salmonella contamination. The recall was initiated after FDA received a single complaint reporting 5 illnesses and FDA sampling revealed the presence of Salmonella in the product.

Allergy Alert: Frickenschmidt Foods LLC recalls HIGH PROTEIN SNACK TERIYAKI BEEF WICKED CUTZ BEEF STICK (1.5 oz individual packs; Lots 113022, 120122, and 012823; Packaged on Nov. 30, 2021, Dec. 1, 2021, and Jan. 28, 2021, respectively) due to undeclared gluten.

Canada

Allergy Alert Update: Frobisher International Enterprises Ltd. recalls 3Fish brand Sauerkraut Fish (Szechuan Style) (400g; 8 74718 00529 5; All codes that do not declare milk on the label) and Tilapia Soup with Pickled Vegetables (400g; UPC 8 74718 00534 9; All codes that do not declare milk on the label) due to undeclared milk. The recalled products have been sold in British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, and Quebec and may have been distributed in other provinces and territories.

Food Safety Recall: Boucherie Rossignol inc. (La Pocatière, QC) recalls SAUCE À LA SAUCISSES  / Sausage sauce and SOUPE LÉGUMES MAISON / Homemade vegetable soup (500 ml and 1 L; Sold up to and including 22 February 2022) due to lack of mandatory storage temperature labeling.

Food Safety Recall: Boucherie St-Hilaire (Jonquière, QC) recalls SAUCE À LASAGNE / Lasagna sauce (Units sold up to 23 February 2022) due to lack of mandatory storage temperature labeling.

Europe

Powdered Infant Formula Safety Recall (Italy): Abbott SRL recalls Similac – Alimentum powdered infant formula (400g; Lot 29280Z260X; Best before 01-06-2023) due to possible contamination with Salmonella and Cronobacter.

Powdered Infant Formula Safety Recall (Italy): Abbott SRL recalls Similac – Elecare powdered infant formula (400g; Lot 27930Z202X; Best before 30-09-2022) due to possible contamination with Salmonella and Cronobacter.

Powdered Infant Formula Safety Recall (Netherlands): Abbot B.V. recalls Similac Elecare (400g; Lot #27930Z20; Best before September 2022) due to possible contamination with Salmonella and Cronobacter.

Powdered Infant Formula Safety Recall Update (UK): Abbott recalls various batches of Elecare Similac and Alimentum Similac infant formula powders due to possible contamination with Salmonella and Cronobacter. Please refer to the recall notice for a complete list of affected products.

Allergy Alert (Belgium): ALDI recalls Bistro’Vite brand Vol-au-vent (1 kg; Lot #27004500; Expiry date 03/03/2022) due to undeclared soy and/or celery.

Allergy Alert (Luxembourg): ALDI recalls Bistro’Vite brand Vol-au-vent (1 kg; Lot #27004500; Expiry date 03/03/2022) due to undeclared soy and/or celery.

Allergy Alert (Spain): Spanish Agency for Food Safety and Nutrition warns consumers that HIBER brand PASTAS DE TÉLLENAS / Filled tea cakes (200g; Batch No. 20.01.22; Expiration date 03.21.22) contains undeclared eggs.

Food Safety Recall (France): SOCIETE TRIDIS LECLERC TRIE-CHÂTEAU recalls Chaire à saucisse / Sausage meat (All lots; Use by dates between 12/02/2022 and 16/02/ 2022) due to Salmonella contamination.

Food Safety Recall (France): Vallégrain Distribution recalls Vallégrain brand Rôti façon Orloff / Orloff-style roast (~1 kg; Lot 2204809601; Use by 27/02/2022) due to Salmonella contamination.

Food Safety Recall (France): SOCIETE COOPERATIVE APPROVISIONNEMENT – SCAPMAREE E.LECLERC recalls EMILE FOURNIER ET FILS brand FLT MAQ FUME PROV BIO SKIN P/ANE / Smoked mackerel filets (200g; Lot 2204507; Use by 16/03/2022) due to Listeria monocytogenes contamination.

Food Safety Recall (France): DEMARNE recalls LA BARRE brand FILET HARENG FUME SOUS VIDE / Vacuum-packed smoked herring (~1 kg; Lot 044121/20; Use by 05/03/2022) due to Listeria monocytogenes contamination.

Food Safety Recall (France): SCAMARK E.LECLERC recalls RONDE DES MERS brand TRANCHES POUR TOASTS SAUMON FUME / Smoked salmon slices (4 slices / 80g; Lot F0280269; Use by 02/03/2022) due to possible Listeria monocytogenes contamination.

Food Safety Recall (France): GAEC LA BAROTIERE recalls GAEC LA BAROTIERE brand FROMAGE DE CHEVRE FERMIER / Farmer’s goat cheese (Lot 43; Best by 18/04/2022) due to possible Listeria monocytogenes contamination.

Food Safety Recall (Iceland): Reykjagarði ehf. recalls Holta, Kjörfugl and Króna brands of chicken – Complete bird and breast (Traceability number 001-22-01-6-16; Pack dates 15.02.22 and 16.02.22) due to Salmonella contamination.

Food Safety Recall (Netherlands): Maza Mediterranean Delicacies recalls Esfenaj (200g; Best before 19-03-2022) due to Listeria monocytogenes contamination.

Food Safety Recall (Netherlands): Maza Mediterranean Delicacies recalls Hoemoes less salt / Hummus, reduced salt (200g; Best before 28-03-2022) due to Listeria monocytogenes contamination.

Food Safety Recall (Romania): Dr. Oetker Ro SRL recalls Pizza Ristorante Prosciutto / Restaurant-style prosciutto pizza (330g; Lot #141021; Expiry date 09.2022) due to possible foreign matter (metal) contamination.

Food Safety Recall (UK): Waitrose recalls Waitrose & Partners Green Pesto with Basil (145g; Use by 27 February 2022) due to Salmonella contamination.

Food Safety Recall (UK): Tesco recalls Tesco Hog Roast Style Pork with Apple Sauce (425g; Use by 06 January 2022, 09 January 2022, 15 January 2022, 17 January 2022, 6 February 2022, 8 March 2022, 9 March 2022) due to possible Salmonella contamination.

Australia and New Zealand

Allergy Alert (Australia): Professional Beauty Solutions Pty Ltd recalls three Bestow Powdered Drink Products (various weights and multiple date codes) due to undeclared gluten. Please refer to the recall notice for a complete list of affected products.

Allergy Alert (New Zealand): Janine Tait Group Ltd recalls specific batches and dates of three Bestow Powdered Drink Products due to undeclared gluten. Please refer to the recall notice for a complete list of affected products.