US – Abbott Laboratories, a US-based baby formula manufacturer has entered into a consent decree with the US Food and Drug Administration (FDA) relating to its Sturgis, Michigan, infant formula plant.
The decree is an agreement on the steps necessary to resume production and maintain the facility. This does not affect any other Abbott plant or operation and the decree is subject to court approval.
The laboratory says it could reopen its doors and start production in two weeks once the FDA confirms the initial requirements for start-up have been met.
The company and the US Food and Drug Administration did tests on finished products during an inspection of the facility and the results came back negative for cronobacter and/or salmonella, Abbott added.
The company further says although the results came out negative, the watchdog provided a list of observations that point out where Abbott did not follow our processes and where we can improve our systems and protocols.
The recall and closure of its Michigan plant came after four children who consumed infant formula made at the plant became sick from cronobacter sakazakii and salmonella infections. Abbott says the infections are not linked to formulas manufactured at the facility.
The recall has sparked a shortage of specialized products critical to keeping some infants fed causing worries in the US market.
The gaps on the shelves have been exacerbated by worried parents stocking up on supplies leading to the increased importation of this product not usually sold there.
According to Datasembly insight, the percentage of formula out-of-stock in the US has reached at least 40%, with specific metro areas as high as 57%.
Last week, in a statement, the company said it was releasing limited quantities of metabolic nutrition formulas that were previously on hold following its recall of powder infant formulas.
The lots being released were not included in the February recall and are being released at the request of the US Food and Drug Administration (FDA).
Meanwhile, the FDA has issued a statement saying it is working to “alleviate supply issues” in the market for specialist infant formula, including making it easier to import products into the US.
It has increased flexibilities regarding the importation of certain infant-formula products to further increase the availability of infant formula across the country while protecting the health of infants.
According to the White House, after President Biden spoke with executives of Nestlé and Reckitt Benckiser, Nestlé’s Gerber arm had increased the amount of their infant formula available to consumers by approximately 50% in March and April, while Reckitt is supplying more than 30% more products to date.
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