Nathan Wilson | Reporter
A spate of sick infants in Sept. 2021 ended with the February closure of Abbott Nutrition’s infant formula production facility in Sturgis, Mich. The FDA identified four infants who were hospitalized in the US, with two dying after ingesting formula from the Abbott facility.
Hillary Ward of Black Lake is raising her seven-month-old daughter Iris with a combination of Similac Sensitive and Gerber Good Start Gentle. “Whichever one of those we can find is what we buy,” she says. “(We) count on people to make sure things are right, especially for an infant,” she says. “You’re providing their nourishment or they’re not going to make it.”
Along with Similac Advance, Alimentum and Pro-Total Comfort, Similac Sensitive was among the varieties of formula linked to consumer complaints of infant illness. A class action suit by a Florida-based law firm and statements from regulators in the UK suggest more infants were affected. Two products, Alimentum and Similac for Spit-Up, tested positive for bacterial contamination during the ensuing FDA inspection that led to the plant’s closure.
In the four documented illnesses, the microbe responsible was identified as Cronobacter sakazakii, a bacteria found in dirt. Ingestion of the bacteria can cause severe illness including meningitis and sepsis. A fifth illness resulting from a strain of Salmonella wasn’t conclusively linked to the plant. A subsequent investigation by the FDA identified Cronobacter contamination of dozens of surfaces throughout the plant including equipment that came in direct contact with the finished product and identified as “high care” by the plant’s staff.
Ward identifies and remedies safety risks at her workplace. She describes safety review processes as an ongoing exercise in improvement. “Every building, every organization has things pending safety-wise and some are minor, some aren’t, but if they’re major items those are items that no matter what should be taken care of,” she explained. She practices treating hazardous conditions with a sense of urgency, so she tempered her concern over the recall with the recognition that the problem was addressed swiftly. “I do understand things happen and I appreciated them having a recall quickly,” she said.
The limited number of reported illnesses lends itself to the perception that Abbott reacted quickly, but the recall initiated Feb. 17 occurred more than a month after Abbott management signed the final medical and quality assessments in one of the two documented fatal cases of contaminated formula, and only after an investigation by a dozen FDA officials.
In their report, FDA investigators criticized plant management for attempting to close the case without taking steps to determine the cause of the illnesses including failing to adhere to investigation protocols by testing samples it held in storage. The inspector’s most serious criticism accuses plant officials of downplaying the seriousness of consumer complaints. “Your complaint investigations treated infant death and infant illness the same,” it concluded.
A 2021 inspection had previously documented FDA inspector’s concerns ranging from absent or improperly maintained equipment to inadequate monitoring of critical processes such as pasteurization, which is used to sterilize food products for safe storage. In their 2022 investigation, FDA officials noted some of the concerns they had raised during the 2021 inspection had gone uncorrected. Referencing their 2021 report, FDA officials indicated that puddles of standing water observed in the plant in 2021 were still present months later, leading to unsanitary conditions.
Though she isn’t familiar with details of the plant’s condition, Ward’s impression of Abbott’s response soured after she learned their issues were long-standing. “Whether it’s at Wal-Mart and spilled water or whatever the concern is, the impact is what you look at.” she says. “As a parent it’s frustrating to know that whoever had that position at that plant, or whatever committee, no one was fighting to get things corrected.”
The plant management’s unwillingness to correct safety and sanitation issues were the subject of a whistleblower complaint filed with the FDA in October, 2021 by a former employee in the quality systems unit. The complaint was issued after one infant was sickened, but before any deaths were reported. The complaint characterizes senior plant staff as working to hide evidence of contamination and obstruct FDA oversight.
The complaint alleges that plant officials routinely falsified records, failed to implement corrective measures and proceeded to distribute untested product from batches which had previously failed testing for contamination by microorganisms. The complaint further states plant management “celebrated” efforts to prevent FDA auditors from learning the extent of problems at the plant in 2019. The FDA inspection in 2019 yielded a single violation: that plant staff had tested only half the number of samples mandated by the companies quality assurance protocols. According to the complaint, the whistleblower was terminated in response to repeated attempts to alert plant management of unsafe practices, and is subject to an investigation by OSHA.
With evidence mounting that senior FDA officials were never made aware of the whistleblower report, and that senior plant staff actively undermined oversight efforts, the seriousness and persistence of violations is now the subject of a congressional investigation. The whistleblower complaint suggests there may be ample desire among plant staff to share information. “Countless current employees want this information disclosed to enforcement officials. They are rightly fearful of retaliation,” it alleges.
It is not clear whether the plant’s management will face punishment. The Justice Department simultaneously filed a complaint and a proposed consent decree against the plant May 16. Abbott and three members of the plant’s management team, Keenan Gale, Quality Assurance Director; TJ Hathaway, Site Director; and Lori Randall, Director of Quality, are identified as defendants in the complaint which seeks an injunction against further production of contaminated products. The accompanying consent decree would mandate that Abbott correct the issues facing the plant before resuming operations but allows the company and its managers to maintain their innocence for the time being.
An FDA official communicating with Natchitoches Times staff on background offered insight into the role FDA inspections play in enforcing food safety. “The FDA conducts inspections to verify that manufacturers have systems and processes in place to produce quality products and that they maintain acceptable practices in their day-to-day operations,” the official stated while indicating that most firms are allowed to voluntarily correct concerns raised by inspectors. “For egregious deviations from the regulations or instances of repeated observations, the agency takes immediate action,” the official added.
Relying on site administrators to voluntarily correct violations did not work at the Sturgis plant, and a frequently asked questions (FAQ) page published by the FDA suggests that the warnings, called Form 483, that FDA inspectors issue to plant management doesn’t carry the threat of immediate penalties. “FDA Form 483 is presented and discussed with the company’s senior management. Companies are encouraged to respond… in writing with their corrective action plan and then implement that… plan expeditiously,” says the FAQ.
Casey Green’s son Jonathan was born in late April after the contaminated stock was recalled. At first, she was unaware of the formula shortage because of her decision to breastfeed her child. “Around the beginning of May people started asking how we were doing with formula and we were relieved because I was breast feeding,” she says. She was forced to change plans when she realized her son would need supplemental nutrition. “In mid-May it became clear that my son was not gaining weight, and his pediatrician advised us to start adding formula to his diet.” she says.
Despite having avoided the contaminated formula, Green is disturbed by the implications for her child’s safety. “I have read about the issues at the Michigan plant and why the recall was ordered. Frankly, the thought that my son’s formula might be contaminated is too much for me to think about.” she says. “He needs formula to be happy, healthy and thrive. If I think that his formula might harm him, I will be reluctant to give it to him. The anxiety is too much, so I just try not to think about it.”
Ward is also concerned about Abbott’s Sturgis plant returning to operation. “Once they do start making it, is anybody cutting corners? Should I worry? Are they just trying to get product out there to suffice the need, or are we following everything we need to make sure?” she asks.
Abbott resumed production of Elecare and other specialty formulas at its Sturgis plant on June 4, and expects to resume full production in the coming weeks.