Chair of the House Appropriations Committee – Rep. Rosa DeLauro (D-Conn.) – released the complaint late in April 2022, right after she received it. The congresswoman called its allegations “extremely disturbing.”
Abbott Baby Food Recall – Cronobacter sakazakii bacteria
Abbott recalled three popular brands of powdered infant formula in February 2022 after reports that four infants who drank formula from the facility had fallen ill with rare and serious infections caused by Cronobacter sakazakii bacteria. Two of the babies died. The facility halted production.
In a statement posted on its website, Abbott said it was working closely with the FDA to restart the plant’s operations.
The former Abbott Laboratories’ Sturgis site employee stated that he saw records falsified “on multiple occasions.” He also said that in most situations, Abbott failed to disclose information when it should have.
The employee reported in the complaint that he observed events that Abbott understated or inaccurately described “to limit or avoid oversight.” He further accused Abbott of “failing to maintain accurate maintenance records.”
For one example, after several samples of an infant formula batch were found to contain microorganisms – or “micros” – the whistleblower claims Sturgis plant workers performed a time code removal. That means formula produced around the same time as the contaminated samples was discarded but produced outside of those time codes was released for sale without more testing to make sure it was safe to eat.
Further, the complaint says that Abbott failed to recall product from the market in 2020 even after becoming aware of a problem with packaging integrity. The whistleblower said that knowledge should have caused Abbott to remove the product from shelves and conduct more testing.
While the complaint says Abbott fired the employee for raising safety concerns, Abbott disputes the employee’s position.
“Abbott takes employee concerns very seriously, and we foster a culture of compliance to produce the best and highest-quality formula,” the company said in a statement last month. “We empower our employees to identify and report any issues that could compromise our product safety or quality, which comes before any other considerations.
“With regard to the document released by Congresswoman Rosa DeLauro (D-Conn.), this former employee was dismissed due to serious violations of Abbott’s food safety policies. After dismissal, the former employee, through [an] attorney, has made evolving, new and escalating allegations to multiple authorities. Abbott is reviewing this new document and will thoroughly investigate any new allegations.”
According to the whistleblower’s complaint:
“Others also raised concerns, some with management but more often among colleagues at the Sturgis site. Given the overriding fear of retaliation, few were as outspoken as the Complainant. Ultimately despite an admirable employment record at Abbott and elsewhere, Complainant was terminated based upon his repeated elevation of compliance concerns.”
The document says OSHA is investigating Abbott’s termination of the man’s employment.
The complaint also says managers may have been “sanitizing” files before they reached FDA inspectors:
“Active efforts were undertaken and even celebrated during and after the 2019 FDA audit to keep the auditors from learning of certain events believed to be associated with the discovery of micros in infant formula at the Sturgis site.”
The complaint also accuses the Sturgis site of lax cleaning practices.
“I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility,” Rep. DeLauro said in a statement read into the record of an Appropriations Committee hearing. “We need to know exactly who in the company was aware of this failure and the alleged attempts to hide this information from the FDA.
DeLauro has asked the inspector general of the US Department of Health and Human Services to scrutinize the FDA’s response, which she felt was too slow.
The FDA told CNN: “[T]his remains an open investigation with many moving parts. Our top priority is ensuring that any recalled product produced at the Sturgis, Mich. facility has been removed from the market. We are continuing to investigate and will continue to update our consumer alert should additional consumer safety information become available.
“Once the immediate risk to the public has been addressed, we will conduct a review and, as outlined in our recently released Foodborne Outbreak Response Improvement Plan, we will build in performance measures across the FDA’s foods program to better evaluate the timeliness and effectiveness of outbreak and regulatory investigation activities,” the FDA said in a statement.
Cronobacter Infections from Powdered Baby Formula
While cronobacter infections in infants are usually caused by contaminated powdered baby formula, Cronobacter can be caused during manufacturing, but also after consumers open formula containers at home.
Formula types included in the recall include:
- Similac Sensitive
- Similac Pro-total Comfort
- Similac Advance
- Similac PM 60/40, Alimentum and EleCare
Abbott Nutrition is also the exclusive supplier for many state WIC programs. WIC, or Special Supplemental Nutrition Programs for Women, Infants, and Children, supplies food to low-income mothers and their young children.
Inspection reports CNN obtained through a FOIA request revealed several deficiencies at the Sturgis facility. FDA testing found Cronobacter sakazakii bacteria on equipment in the plant. The FDA determined Abbott did not take steps to prevent products from becoming contaminated during manufacturing.
A statement Abbott posted on its website in March 2022 said it was reviewing the FDA’s observations. Abbott also said that its own company testing found no Cronobacter sakazakii or Salmonella in any of Abbott’s testing of products distributed to consumers. Abbott also said the “unique genetic makeup of the Cronobacter sakazakii microbes found in non-product contact areas at the Sturgis facility did not match the Cronobacter sakazakii microbes from the reported cases.”
Abbott said, “A thorough review of all available data indicates that the infant formula produced at our Sturgis facility is not likely the source of infection in the reported cases and that there was not an outbreak caused by products from the facility.”