The original text of the following article is translated from “many baby formula plants were’t inspected because of covid” published by the associated press on June 13, 2022, compiled by snack generation, with slight deletion.
(image source: AP)
According to the relevant inspection records reviewed by the associated press, over the years, US regulators have inspected infant formula factories at least once a year. However, in 2020, US regulators did not inspect any of the three major milk powder manufacturers.
After two years, they finally entered Abbott’s milk powder factory in Michigan and found that there was water accumulation and lax sanitation procedures. However, the inspectors only provided suggestions for them to deal with these problems voluntarily, and did not issue a formal warning.
After four infants who ate the milk powder from the factory were accused of bacterial infection, the inspectors re entered the Abbott Michigan milk powder factory five months later. They found bacterial contamination in the factory, which eventually led to the closure of the factory for four months. At the same time, the worsening milk powder crisis due to supply chain shortage has turned into a comprehensive “milk powder shortage”. American parents rushed to find formula milk powder, forcing the United States to airlift milk powder from overseas.
The gap in the number of inspections of infant formula factories caused by the COVID-19 is under a new round of review by Congress and regulators to investigate a series of mistakes that led to the crisis. A recent Act requires the US Food and Drug Administration (FDA) to inspect infant formula facilities every six months. The inspector general of the U.S. Department of health and human services has investigated the U.S. Food and Drug Administration for its handling of the largest Abbott Laboratories in the United States.
Abbott resumed production at the plant earlier this month under a legally binding agreement with the US Food and drug administration. However, the shutdown of the factory and the nationwide shortage of milk powder have exposed that the milk powder industry in the United States has been highly concentrated, and a few companies have seized about 90% of the market share.
With the COVID-19 sweeping the United States in early 2020, the U.S. Food and Drug Administration withdrew most of its safety inspectors from the inspection front and canceled thousands of routine factory inspections.
In a statement, the U.S. Food and Drug Administration said that in the first year of the outbreak of the COVID-19, the U.S. Food and drug administration carried out more than 800 “mission critical” inspections. The agency selectively inspects some factories according to whether there are specific safety risks or whether it is necessary to produce important drugs.
Only 3 of the 23 factories producing, packaging or distributing formula milk powder in the United States have been “selected” for inspection. The U.S. Food and Drug Administration resumed routine inspections in july2021.
According to the inspection records reviewed by the associated press, the US Food and Drug Administration inspected the factories of the three major formula manufacturers (Abbott, Rexroth and Garbo) in 2019. After two and a half years, it inspected these factories again.
In fact, according to the records of the U.S. Food and drug administration, there is an important Li Jieshi factory and two Garbo factories that have not been inspected. These factories are currently operating around the clock to increase the production of formula milk powder in the United States.
“If the U.S. Food and Drug Administration conducts inspections during the outbreak (at Abbott’s Michigan plant), they will have more opportunities to discover these problems,” said Sarah sorscher, a food safety expert at the center for Science in the public interest. She agreed that the food and Drug Administration withdrew inspectors from the front line to protect employees, which was a difficult decision to weigh. “Of course, protecting their employees during that time comes at a price.” Snack notes:
In response to a query about the gap in the number of inspections, the US Food and Drug Administration told the associated press that infant formula manufacturers “have always been regarded as the top priority during the epidemic”, and there is no backlog of inspections at present. The agency said that due to the COVID-19, it skipped about 15000 inspections in the United States, but has made up about 5000 of them, exceeding its target.
According to the current law, the U.S. Food and drug administration only needs to inspect the formula factory once every three to five years, but the agency has been inspecting it once a year – until the outbreak of COVID-19.
“Our top priority now is to address the urgent demand for infant formula in the U.S. market, and our team is working around the clock to help achieve this goal,” the U.S. Food and Drug Administration said.
However, external experts said that the gap in the number of inspections showed the blind spot of the government’s response. The government has been successful in preventing the shortage of drugs and other medical supplies.
Robert California, Commissioner of the US Food and drug administration, said that the agency knew that closing the Abbott Michigan plant would cause supply problems. However, until inspectors closed the plant in February and recently took emergency measures to allow more products to be imported from abroad, there was little evidence of urgency.
Food safety experts have seen the long-standing deeper problems of the management of the U.S. Food and drug administration. For decades, doctors and medical scientists have placed the regulation of drugs and medical products above food.
Steven mandernach, executive director of the association of food and Drug Officials (AFDO), which represents state governments, said: “it is very challenging for them to participate in this field because they do not have the background, knowledge and experience in this field.”
The U.S. Food and Drug Administration and the U.S. Department of agriculture jointly oversee food production and safety. Although the US Congress has increased funds and powers, the number of inspections of food factories by the US Food and Drug Administration peaked in 2011 and has declined in most years since then. The U.S. Food and Drug Administration said that although inspections of U.S. factories have decreased, its inspections of foreign factories have increased.
At present, it cannot be determined that during the COVID-19, the
However, the factory did have problems earlier, including the formula recall in 2010, because the products may be contaminated by “insect carcasses”.
“I think it should be one of the key tasks of the U.S. Food and drug administration to [inspect] factories that have problems and may lead to food safety risks,” mandernach said. “This factory (Abbott Sturges factory) is one of them.”
Mandernach pointed out that the lack of regular inspection of facilities – even those at risk – would change the culture of factories like Abbott.
“If you were driving on the highway and knew that the state police were not there, would you drive faster than if you knew that a police officer was on duty?” Mandernach asked.
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