Abbott Nutrition, which reached a deal with the U.S. Food and Drug Administration (FDA) Monday to restart its Sturgis, Michigan plant, has to take corrective actions to its manufacturing process before resuming production.
Abbott is obliged to “take actions that are expected to ultimately result in an increase of infant formula products, while ensuring that the company undertakes certain actions that would ensure safe powdered infant formula is produced at the facility,” the FDA said in a statement Monday.
After production starts, it will take six to eight weeks before the product is available on shelves.
To ease the fears of parents, who have been scrambling for baby formula for several months, Abbott said it’s already started implementing corrective actions and enhancements at the facility, which has been closed since February due to contamination issues, “to give parents and customers renewed confidence in the quality of manufacturing” at the plant.
ABBOTT SAYS IT WILL BE AT LEAST TWO MONTHS BEFORE BABY FORMULA FROM SHUTTERED PLANT HITS SHELVES
This includes consulting with experts to implement new technology in the manufacturing process such as adding a “3D augmented reality system, which will provide a clearer visualization of product as it moves through the facility,” Abbott said. This will make it easier for the company to make informed decisions during the manufacturing process, according to Abbott.
It’s also increased its finished product testing, which Abbott says “already meets or exceeds regulatory requirements.”
It has also added auto sampling technology throughout the manufacturing line which will “further enhance the speed with which any potential manufacturing issues are identified,” according to Abbott.
Abbott has also upgraded its environmental monitoring program “by increasing the sampling of non-product contact areas by two to three times.”
The company also made sure its electronic records provide immediate real-time information for each batch.
Abbott initially issued a voluntary recall of certain powdered formulas made at its Sturgis facility after four complaints that babies who consumed products from the plant became sick from bacterial infections. Two of the infants died.
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The company said, “after a thorough review of all available data, there is no evidence to link our formulas to these infant illnesses.” Still, Abbott acknowledged that its recall worsened the industry-wide formula shortage. Over the past several months, the company says it’s been taking specific actions to get as much product into the hands of parents as possible.
This includes shipping millions of cans of infant formula powder into the U.S. from its Ireland facility, which is FDA-registered. Abbott also been prioritizing production at its facility in Columbus, Ohio, where the company says it’s been “converting other liquid manufacturing lines into manufacturing Similac liquid ready-to-feed.”
Its other plants are also running at full capacity.
It’s also offering coupons for all of its infant formula products such as Similac ready-to-feed, allowing customers to purchase the formula at a deep discount or even get it for free.
Recently, the company announced that it will also extend its WIC reimbursement for competitive products through Aug. 31.
“Abbott has been working with the USDA and WIC agencies and paying rebates on competitive products in states where Abbott holds the WIC contract, when Similac is not available,” Abbott said. “This means program participants will continue to be able to obtain formula, free of charge whether it is Similac or formula from another manufacturer.”
The Associated Press contributed to this report.
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