(WHTM) — Healthcare company Abbott released a statement about the current findings in their Sturgis, Michigan facility and supply on Wednesday, May 11. Their statement comes in the midst of the national infant formula shortage.
Back in February of 2022, there was a voluntary recall involving four complaints of Cronobacter sakazakii, a common environmental bacteria, in infants who consumed infant formulas produced in this plant. Two infants became sick, and two other infants passed away because of the bacteria.
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After a thorough investigation and a review of all the available data, there is no evidence to link Abbott formulas to infant illnesses.
In the statement released by Abbott, they said the following:
- Abbott conducts microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella.
- All finished product testing by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter and/or Salmonella. No Salmonella was found at the Sturgis facility.
- The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of the facility and has not been linked to any known infant illness. Specifically:
- Genetic sequencing on the two available samples from ill infants did not match strains of Cronobacter in our plant. Samples from ill infants did not match each other, meaning there was no connection between the two cases.
- In all four cases, the state, FDA, and/or CDC tested samples of the Abbott formula that was used by the child. In all four cases, all unopened containers tested negative.
- Open containers from the homes of the infants were also tested in three of the four cases; two of the three tested negative. The one positive was from an open container from the home of the infant, and it tested positive for two different strains of Cronobacter sakazakii, one of which matched the strain that caused the infant’s infection, and the other matched a strain found on a bottle of distilled water in the home used to mix the formula. Again, neither strain matched strains found in our plant.
- The infants consumed four different types of our formula made over the course of nearly a year and the illnesses took place over several months in three different states.
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- [Abbott Nutrition] did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment.
- [Abbott Nutrition] did not ensure that all surfaces that contacted infant formula were maintained to protect infant formula from being contaminated by any source.
Because of these findings, the facility was shut down. Abbot released a statement about their work to reopen the plant:
The FDA concluded its inspection with a 483 letter to Abbott on March 18. This is a list of observations that point out where Abbott did not follow our processes and where we can improve our systems and protocols.
We take this very seriously and we responded to the 483 on April 8. Even before our formal response, we had begun working to address these issues, implement improvements and take corrective action. Some of these actions have included reviewing and updating education, training and safety procedures for both employees and visitors, as well as updating our protocols regarding water and cleaning and maintenance procedures at the facility. We immediately implemented corrections to address the items the FDA raised in the 483. We’ve also been making upgrades to the plant, including installing nonporous, easily cleanable and sanitary floors.
We know the recall has worsened an already existing industry-wide infant formula shortage in the U.S. and we’ve been seeing and hearing the stress and despair of parents who are facing empty shelves. We deeply regret the situation and since the recall, we’ve been working to increase supply at our other FDA-registered facilities, including bringing in Similac from our site in Cootehill, Ireland, by air and producing more liquid Similac and Alimentum. We also began releasing metabolic formulas that were on hold earlier this month at FDA’s request to those who need these unique formulas.
We understand the situation is urgent – getting Sturgis up and running will help alleviate this shortage. Subject to FDA approval, we could restart the site within two weeks. We would begin production of EleCare, Alimentum and metabolic formulas first and then begin production of Similac and other formulas. From the time we restart the site, it will take six to eight weeks before product is available on shelves.Statement from Abbott, May 11, 2022
This comes after President Biden and other lawmakers said that they are working on the issues.
“So our message to parents is – we hear you, we want to do everything we can and we are going to cut every element of red tape to help address this and make it better,” White House Press Secretary Jen Psaki said.
President Biden is taking steps to try to address the shortage by cutting red tape for manufacturers, increasing foreign imports, and calling on the FTC and state attorneys general to crack down on price gouging.
When asked how long the shortage would last, the White House has said they are unsure of a time frame on when the supply can improve.
For information on what to do during this infant formula shortage, click here.