When they finally entered an Abbott Nutrition formula factory in Michigan after a two-year hiatus, they found stagnant water and loose hygiene procedures. But the inspectors offered only voluntary suggestions to solve the problems and did not issue a formal warning.
The inspectors would return five months later after four infants consuming formula from the plant had bacterial infections. They found a bacterial infection inside the factory, which led to a four-month shutdown and turned a severe supply shortage into a complete crisis that pushed parents to find a formula and forced the US to ship products from abroad.
The gap in plant inspections for baby products caused by the COVID-19 pandemic, receives new scrutiny from Congress and government authorities investigating the series of failures that led to the crisis. A recent bill would require the Food and Drug Administration to inspect baby care facilities every six months. And the government’s inspector general of health has launched an investigation into the handling of the Abbott plant by the FDA, the largest in the US
Abbott resumed production at the plant earlier this month under a legally binding deal with the FDA, but the closure and nationwide shortage revealed how concentrated the industry has become in the US, with some companies accounting for about 90% of the market. .
As COVID-19 swept the United States in early 2020, the FDA withdrew most safety inspectors from the field, bypassing thousands of standard factory inspections.
The FDA did conduct more than 800 inspections of “critical missions” during the first year of the pandemic, the agency said in a statement. Regulators selected facilities for inspections based on whether they posed a specific safety risk or were needed to produce a significant medical treatment.
Only three of the nation’s 23 facilities that produce, package or distribute formula made the cut. The FDA resumed routine inspections in July 2021.
Inspection records reviewed by the AP show gaps as large as 2 1/2 years between FDA inspections in 2019 and when regulators returned to factories owned by the top three manufacturers: Abbott, Reckitt and Gerber.
In fact, the FDA has not yet returned to one major plant owned by Reckitt and two owned by Gerber, according to agency records. All of these facilities operate around the clock to enhance US formula production.
“The FDA would be more likely to address these issues if it inspected during the pandemic,” said Sarah Sorser, a food safety expert at the Center for Public Interest Science. He acknowledged the difficult compensation the FDA faced to persuade its inspectors to reduce their exposure to COVID-19. “There was definitely a price to pay for protecting their employees at that time.”
Manufacturers of baby milk “were consistently identified as a high priority during the pandemic” and there are currently no delays in inspections, the agency said in response to questions about the gaps. The agency said it missed about 15,000 inspections in the United States because of COVID, but has already done about 5,000 of them, exceeding its own targets.
Under current law, the FDA is only required to inspect the facility every three to five years, but the agency consistently inspects the facility annually – until the pandemic.
“Our top priority now is to address the urgent need for baby milk in the US market and our teams are working day and night to help make that happen,” the FDA said.
However, outside experts say the gap in inspections shows a blind spot in the government’s response effort, which has been successful in preventing shortages of medicines and other medical supplies.
FDA Commissioner Robert Califf says regulators knew the closure of the Abbott plant would cause supply problems, but there was little evidence of urgency between inspectors closing the plant in February and recent emergency measures to allow more imports from the plant. abroad.
Food safety experts have long seen a deeper problem at the highest levels of the FDA, where doctors and medical scientists have for decades prioritized the oversight of medicines and medical products over food.
“It’s very difficult for them to deal with this sector at all, because they do not have the background, knowledge and experience in it,” said Steven Mandernach, executive director of the Food and Drug Administration, which represents the state. -level inspectors.
The FDA shares oversight of food production and safety with the US Department of Agriculture. FDA inspections of food establishments peaked in 2011 and have declined most years since, despite increased funding and powers from Congress. The FDA said that while inspections in the US have decreased, inspections of foreign facilities have increased.
There is no certainty that additional inspections during COVID-19 would have prevented contamination problems at the closed Sturgis plant in Michigan. And Abbott says its products have not been directly linked to infections, two of which have been fatal.
But the plant had previous problems, including formula recall in 2010 due to possible contamination with insect parts.
“I think facilities that had known problems that could pose a risk to food safety should be part of the FDA’s critical mission,” Mandernach said. “And this facility would be among them.”
Lack of regular inspections – or even the threat of them – can lead to changes in the cultivation of plants such as Abbott’s, Mandernach noted.
“If you drive on the highway and you know that the state soldiers have been fired, could you go a little faster than if you knew there was a soldier on duty?” Madernach asked.
The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Education Department. The AP is solely responsible for all content.
Copyright © 2022 by the Associated Press. All rights reserved.
Baby formula shortage 2022: Many plants weren’t inspected because of COVID Source link Baby formula shortage 2022: Many plants weren’t inspected because of COVID