A former supervisor in a baby formula plant linked to infant deaths earlier this year — now at the center of an ongoing formula shortage — has stepped forward to describe a facility with constant roof leaks, lax food safety and recordkeeping, and a culture of fear, raising new questions about why such problems were allowed to continue and the FDA did not discover them earlier.
The former frontline leader, who worked at Abbott Nutrition’s formula plant in Sturgis, Mich., for multiple years, is the second employee to raise concerns about conditions and management at the plant, once responsible for about a fifth of the U.S. formula supply. The former supervisor was granted anonymity because of their fear of retaliation in the industry.
The former supervisor, who had direct knowledge of the plant’s operations, described an atmosphere in which maintenance problems that could promote bacterial growth weren't promptly fixed, there were constant roof leaks, equipment was not always properly designed to keep food safe and records were not always accurate — all problems that had gone undetected during annual FDA inspections in recent years.
“The plant would prep heavily before audits,” the former supervisor said. “The plant basically turned into a movie set where only things the higher ups wanted the FDA to see were seen.”
The revelations come after the plant reopened for production July 1. The plant had been shut down from February to June after the FDA found insanitary conditions in the plant. The plant briefly re-opened then shut down again after a severe storm in mid-June left the plant partially flooded.
Despite the plant reopening and a Biden administration effort to fly formula in from Europe and Australia since May, retail stocks of infant formula have worsened and it’s still common for parents to see shelves that are sparse — five months after reports of infant hospitalizations and deaths sparked a massive recall of Abbott Nutrition products.
Abbott disputed the former employee's characterization of the plant.
“The claims made by this unnamed source ... are either inaccurate or completely taken out of context,” said Scott Stoffel, divisional vice president of external communications and public affairs at Abbott.
Stoffel said that without knowing the identity of the person making the claims it was impossible to verify their employment, what they had knowledge of or the circumstances under which they left the plant.
The FDA, asked to explain why problems were not caught earlier, contended that inspections are just one part of food safety oversight and that ultimately it's up to manufacturers to assure the safety of their products every day.
“We take seriously our duty to prevent and respond to foodborne illnesses and food contamination events,” an FDA spokesperson said.
Lawmakers on both sides of the aisle have raised questions about the FDA’s handling of the incident, as questions remain about why federal regulators didn’t take action sooner.
After months of investigation, the FDA has said it cannot definitively link the hospitalizations and deaths to the formula plant, nor can it rule out a link. The agency found five strains of Cronobacter in the plant in early 2022, but none of the strains have matched the limited samples the government has to compare them to. One huge challenge for investigators is that Cronobacter sakazakii, the bacteria to blame, is not a reportable condition, which means that illnesses are not routinely reported to the CDC’s public health monitoring system. This means federal officials lack much of the evidence they’d normally have for an investigation like this.
Still, FDA Commissioner Robert Califf in May blasted the plant for having “egregiously unsanitary” conditions.
“Frankly, the inspection results were shocking,” Califf told lawmakers before a House Energy and Commerce subcommittee hearing on the infant formula debacle — a hearing that repeatedly drew on POLITICO’s reporting on the infant formula timeline as well as broader dysfunction within FDA’s food program.
The former supervisor, whom POLITICO independently confirmed worked at the plant, corroborated many of the warnings that had been raised directly to FDA by a separate whistleblower in Oct. 2021, as first reported by POLITICO. The warnings from the first whistleblower were sent to top FDA officials, but it took the agency months to respond to them, during which time FDA received more reports of infant deaths and hospitalizations from a rare bacterial infection. The agency initially blamed the mailroom, contending that agency leadership didn’t receive the documents, but later conceded that it took too long to act. FDA is now reviewing its handling of the incident.
Abbott has pushed back strongly against that whistleblower, claiming repeatedly that the employee was “dismissed due to serious violations of Abbott’s food safety policies.”
“While at the company, the former employee did not bring forward product safety violations to our Office of Ethics & Compliance or others,” Stoffel said, in a new statement, acknowledging that the employee had also filed a complaint to Michigan OSHA about a situation where an employee fired a stun gun at the plant. (The complaint was later dismissed by the state agency.)
The company said the first whistleblower’s lengthy warning to FDA — which was sent to the agency in October, five months before the agency shut down the plant — “added still more allegations, continuing a pattern of ever-evolving, ever-escalating allegations.”
The former supervisor came forward recently citing many of the same concerns outlined by the first whistleblower, including improper cleaning and recordkeeping, but also described an overarching culture of fear, where employees were discouraged from raising concerns about food safety or other problems to management, as well as a history of cost-saving measures that sometimes conflicted with safety.
“Management purposefully took the largest market share they could in a plant that they knew had issues, that they weren't funding properly — and then when they finally dropped the ball, they left these families that are on fixed incomes with babies completely out to dry,” said the former supervisor.
The former supervisor said they often encountered instances where employees felt they could be fired for raising any type of concern. “I kept hearing over and over and over again, ‘yeah, you’ve got to be careful if you start bringing stuff up. You can just disappear around here,’” the former supervisor said.
The company disputed that the plant had a problematic culture. “Abbott has a customer pledge that we make our products as if they are intended for our own families,” Stoffel said, in an email. “Many of our Sturgis employees come from families who have worked there for generations. They know how important their work is and are committed to quality and safety.”
The Sturgis plant has for the past decade held “daily safety meetings with employees throughout the facility to share information in an open forum about what’s working well and areas for improvement,” Stoffel said.
Management was able to impose a higher level of loyalty because the Abbott Nutrition plant is one of the last large employers in Sturgis, Mich., which has lost other manufacturing jobs, much like the rest of the Rust Belt, the former supervisor said.
Plant management commonly discussed the company’s goals to further dominate the U.S. formula market, they recalled: “Upper management was bragging about it all the time: ‘We're feeding one in five babies and we're going to feed one in four and then one in three from this single plant.’”
The company said these comments were “taken completely out of context.”
“We talk about serving one in five American babies to remind ourselves of the critically important role we play in family’s lives,” Stoffel said.
The new details raise additional questions about the rigor of FDA inspections and the agency’s oversight of infant formula, which is supposed to be among the best-regulated foods.
The Sturgis plant often had plenty of notice before FDA inspectors would show up. For four years in a row, from 2016 to 2019, for example, the agency did its annual inspection at around the same time in September, according to a review of inspection records. Inspections are technically unannounced, but scheduling them at the same time for years made the timing predictable. During that period, the plant was largely given a clean bill of health by the agency. In 2019, the plant was cited for one issue: The company wasn’t pulling the right number of samples in its final products to test for bacteria.
For weeks leading up to the FDA’s visits, employees would pull extra overtime cleaning and conduct more frequent internal audits to find and fix any potential issues ahead of time, the former supervisor said. When the FDA did arrive, it was usually just a couple of inspectors and they largely reviewed the plant’s own records — a common practice that checks to see if a plant has the right control systems in place, but can also limit in-person observation. The Sturgis plant is 787,000 square feet — which is the equivalent of more than 13 football fields — and sits on 94 acres.
The company countered that prepping for audits is not unusual.
“Again, this has been taken completely out of context,” Stoffel said. “Our focus 365 days a year is to provide the highest quality formula. Of course, though, you prepare extensively for visitors just as you would if you were having guests over to your home.”
Infant formula plants are generally inspected by the FDA at least once per year because they produce food for a particularly vulnerable population — not just infants, but also children and adults with special medical needs. During the pandemic, the FDA didn’t show up at the Sturgis plant in 2020, which left a two-year gap. The agency had stopped doing nearly all food safety inspections, except for ones that were deemed “mission critical” on a case by case basis.
“FDA acknowledges that Covid-19, particularly during this early period of the pandemic, impacted FDA’s ability to provide the preferred level of inspectional oversight,” an agency spokesperson said in a statement. “FDA’s temporary change in inspection frequency was FDA’s best adaptation at the time to an unprecedented global pandemic that included balancing the safety of FDA and industry staff.”
When two inspectors did return in 2021 — again around the same time in September, the fifth time in a row they had done so — they cited the plant for some problems, including standing water and some equipment issues, but nothing serious enough to warrant regulatory action.
As POLITICO previously reported, those inspectors were coincidentally in the Sturgis plant the very day the FDA was told that a baby had been hospitalized with Cronobacter sakazakii, a bacteria that causes rare and deadly infections in infants, after consuming formula from the plant. After three more infant hospitalizations were reported, including two deaths, and an interview with the first whistleblower in late December, the FDA went back into the plant in late January and found numerous problems that were not listed in the agency’s inspection report from four months earlier.
The plant had notice that FDA would be coming. The agency revealed to Congress this spring that officials had contacted the company on Thursday, Dec. 30, about coming to inspect again on Monday, Jan. 3. The advance notice was given under FDA’s Covid-19 policy, the agency said.
Abbott requested FDA delay the inspection “due to an ongoing COVID-19 outbreak among its staff.” The agency agreed to a delay. By Jan. 11, however, a third Cronobacter complaint landed at the agency. On Thursday, Jan. 27, FDA told Abbott it was coming to inspect on Monday.
When FDA officials arrived Jan. 31 — a full month after the first notice from the agency — they found there were many, many more examples of water problems, among many other issues that were not cited in the agency’s inspection just four months earlier. Officials noted there had been more than 300 “water events,” such as leaks, condensation and standing water in the production area in the past two years, per the company’s own records.
Roof leaks had been a problem at Sturgis for years, the former supervisor said. Leaks were so common, in fact, the plant kept a stash of special plastic tarp catchers that hooked to the ceiling with hoses at the bottom to deal with the water, they recalled: “It leaked so often and in so many different places throughout the entire plant … the plant had a bunch of those in the stock room, because these leaks would just pop up all the time.”
The FDA did not dispute that there were major differences between the agency’s September 2021 routine inspection and the agency’s for-cause inspection in early 2022, but suggested the agency is looking to make improvements to its oversight of infant formula — something that comes amid pressure from Capitol Hill.
“An FDA inspection only provides a single snapshot in time of the operations, preventive controls, and compliance at a firm,” an FDA spokesperson said. “The firm has a responsibility to implement a constant system of sanitation and food safety controls to produce a safe product in compliance with FDA regulations.”
The spokesperson noted that the agency is currently “conducting an evaluation of our response to this incident to determine what additional steps could be taken to ensure the maximum effectiveness of agency programs and policies related to infant formula and medical food complaints, illnesses, and recalls.”
Abbott disputed that it had constant problems with leaks.
"We have experienced occasional leaks over the years from storms (it’s a 787,000 square-foot facility) but have procedures in place to address immediately and we document in our quality records," Stoffel said.
It wasn’t just that the roof leaked, the former supervisor said, but water leaks also came from HVAC systems that were not large enough to work properly on a handful of packaging lines.
Employees believed the size issue to be a cost-cutting measure.
“They didn't want to spend the money to size the HVAC properly,” the former supervisor said. The system would routinely get overloaded and extra water would “overflow back into the line through the wall,” which presented another potential contamination point.
The company pushed back on this, too: “We have more than 100 HVAC units in our 787,000-square foot facility in Sturgis and invest in them to ensure they are functioning properly.” The spokesperson said the HVAC units are all “sized correctly.”
Controlling moisture is important in any food plant, but it’s particularly important in areas that are handling dry material, in this case dry powdered formula destined to be fed to infants without a so-called kill step, which means the formula won’t be cooked or boiled before being consumed.
While poor conditions in the Sturgis plant have been well-documented by the FDA and others, a federal investigation into whether the reported infant illnesses and deaths were caused by formula made in the plant has not been conclusive. Officials have also lacked key pieces of evidence due to holes in public health reporting.
The FDA in June announced it had received a third report of an infant death from Cronobacter. The agency has not yet said whether it determined the latest death was linked to the formula or not. The case is still under investigation, the agency said. The FDA has received reports of nine infant deaths and dozens of other serious injuries, but the agency has determined three of the reported deaths are “associated” with the investigation.
Abbott maintains there is no link between its plant and any of the infant deaths or hospitalizations.
The Sturgis plant, which was originally built in the 1940s and has expanded several times over the years, was still using equipment that’s several decades old, the former supervisor said. One line, known in the plant as “Line 3,” was still packaging product — mostly EleCare, the plant’s signature elemental formula for those with special medical needs — despite having been first put into use in the 1980s.
“Line three was very old and it was poorly designed,” the former supervisor said. “It was up to code in the 80s. It turns out we’ve learned some things since then.”
Abbott had for years planned to bring on a new line, “Line 5,” to replace that old infrastructure, but the new line struggled to perform due to numerous design short cuts, the former supervisor said. The former supervisor recalled being told by quality personnel that the short cuts were taken to save costs.
“They cut corners and they cut the budget,” said the former supervisor, who had reviewed earlier versions of the plans. Some of those cuts were directly related to food safety. The new packaging line had originally been designed to be what’s known as “clean-in-place,” or CIP, an industry term that essentially means equipment can be automatically cleaned with minimal disassembly, reducing the potential for human error.
Abbott did not dispute that Line 5 had some issues, but pushed back on the suggestion that safety measures were inadequate.
The company challenged the claim that the change from clean-in-place was an issue. “CIP is simply a cleaning method,” Stoffel said. “We determined to use a different cleaning method that’s just as thorough.”
The former supervisor also outlined problems with the Line 5 can-seamer — a machine that seals the formula cans. This particular seamer caused many worker safety and food safety issues, they recalled.
The company acknowledged that there had been “some technical challenges” with this seamer and said that it had been replaced.
“We invested tens of millions of dollars to create a state-of-the art production line,” Stoffel said. “Like with any line, we closely monitor to ensure everything is operating properly.”
House Appropriations Chair Rosa DeLauro, who has publicly lambasted both Abbott and the FDA for the infant formula debacle in recent months, praised the former employee for coming forward with new details about conditions in the plant and questionable management.
“Their revelations highlight Abbott’s investment in profit over people — as the company time and time again seemed more interested in cornering its share of the market instead of ensuring the product we give to our babies meets the highest food safety standards,” DeLauro said in a statement to POLITICO.
“This employee’s accounting of events highlights the need to uncover answers as to what went wrong at Abbott as swiftly as possible,” said the Connecticut Democrat. “I will continue to fight for these answers, and to demand accountability for wrongdoing that led to contaminated product that sickened and even killed several babies. We owe it to American families to get to the bottom of this.”
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By: Helena Bottemiller Evich
Title: ‘A movie set’: Former supervisor at baby formula plant says flaws were hidden
Sourced From: www.politico.com/news/2022/08/04/baby-formula-plant-flaws-hidden-00049721
Published Date: Thu, 04 Aug 2022 03:30:00 EST
