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The Abbott baby formula factory in Sturgis, Mich., has reopened, a move that could ease the nationwide baby formula shortage.
“Abbott is restarting infant formula production at its Sturgis, Mich., facility today after meeting initial requirements agreed to with the U.S. Food and Drug Administration as part of the consent decree entered into on May 16,” according to a company statement issued June 4.
“Abbott is starting production of EleCare and other specialty and metabolic formulas, with initial EleCare product release to consumers beginning on or about June 20. We’re also working hard to fulfill the steps necessary to restart production of Similac and other formulas and will do so as soon as we can.”
The FDA began investigating when at least four infants became ill with Cronobacter sakazakii bacteria after consuming infant formula produced in the Sturgis plant. Two infants died. Several Abbott baby formula products were recalled and the Sturgis plant was shut down for months.
Abbott said an investigation found no evidence to link the formulas to the infant illnesses, though bacteria was found in parts of the factory that didn’t have contact with formula.
The FDA entered into a consent decree with Abbott in mid-May that allowed the plant to reopen if the company took corrective actions, including the implementation of a sanitation plan and an environmental monitoring plan and employee training programs. Abbott must also retain an independent expert to monitor operations.
The Abbott shutdown, along with supply chain problems, contributed to a nationwide shortage of formula. Reuters, citing the data firm Datasembly, reported that about 73% of baby products were out of stock nationwide as of May 22.
The shortage is so severe that the federal government authorized the importing of formula from overseas.
“We understand the urgent need for formula and our top priority is getting high-quality, safe formula into the hands of families across America. We will ramp production as quickly as we can while meeting all requirements,” the Abbott statement said.
A version of this article first appeared on Webmd.com.
The Abbott baby formula factory in Sturgis, Mich., has reopened, a move that could ease the nationwide baby formula shortage.
“Abbott is restarting infant formula production at its Sturgis, Mich., facility today after meeting initial requirements agreed to with the U.S. Food and Drug Administration as part of the consent decree entered into on May 16,” according to a company statement issued June 4.
“Abbott is starting production of EleCare and other specialty and metabolic formulas, with initial EleCare product release to consumers beginning on or about June 20. We’re also working hard to fulfill the steps necessary to restart production of Similac and other formulas and will do so as soon as we can.”
The FDA began investigating when at least four infants became ill with Cronobacter sakazakii bacteria after consuming infant formula produced in the Sturgis plant. Two infants died. Several Abbott baby formula products were recalled and the Sturgis plant was shut down for months.
Abbott said an investigation found no evidence to link the formulas to the infant illnesses, though bacteria was found in parts of the factory that didn’t have contact with formula.
The FDA entered into a consent decree with Abbott in mid-May that allowed the plant to reopen if the company took corrective actions, including the implementation of a sanitation plan and an environmental monitoring plan and employee training programs. Abbott must also retain an independent expert to monitor operations.
The Abbott shutdown, along with supply chain problems, contributed to a nationwide shortage of formula. Reuters, citing the data firm Datasembly, reported that about 73% of baby products were out of stock nationwide as of May 22.
The shortage is so severe that the federal government authorized the importing of formula from overseas.
“We understand the urgent need for formula and our top priority is getting high-quality, safe formula into the hands of families across America. We will ramp production as quickly as we can while meeting all requirements,” the Abbott statement said.
A version of this article first appeared on Webmd.com.
The Abbott baby formula factory in Sturgis, Mich., has reopened, a move that could ease the nationwide baby formula shortage.
“Abbott is restarting infant formula production at its Sturgis, Mich., facility today after meeting initial requirements agreed to with the U.S. Food and Drug Administration as part of the consent decree entered into on May 16,” according to a company statement issued June 4.
“Abbott is starting production of EleCare and other specialty and metabolic formulas, with initial EleCare product release to consumers beginning on or about June 20. We’re also working hard to fulfill the steps necessary to restart production of Similac and other formulas and will do so as soon as we can.”
The FDA began investigating when at least four infants became ill with Cronobacter sakazakii bacteria after consuming infant formula produced in the Sturgis plant. Two infants died. Several Abbott baby formula products were recalled and the Sturgis plant was shut down for months.
Abbott said an investigation found no evidence to link the formulas to the infant illnesses, though bacteria was found in parts of the factory that didn’t have contact with formula.
The FDA entered into a consent decree with Abbott in mid-May that allowed the plant to reopen if the company took corrective actions, including the implementation of a sanitation plan and an environmental monitoring plan and employee training programs. Abbott must also retain an independent expert to monitor operations.
The Abbott shutdown, along with supply chain problems, contributed to a nationwide shortage of formula. Reuters, citing the data firm Datasembly, reported that about 73% of baby products were out of stock nationwide as of May 22.
The shortage is so severe that the federal government authorized the importing of formula from overseas.
“We understand the urgent need for formula and our top priority is getting high-quality, safe formula into the hands of families across America. We will ramp production as quickly as we can while meeting all requirements,” the Abbott statement said.
A version of this article first appeared on Webmd.com.