After Abbott restarts the site, you will need to six up to eight weeks for products to reach store shelves, as they say.
Abbott says it has submitted corrective action to the FDA on April 8th. But even before this official answer, everything worked. on improvements, including the revision and renewal of education, training and safety procedures for employees and visitors, as well as updating protocols regarding water, treatment and maintenance procedures on site.
In addition, Abbott immediately stated this. took action to resolve items what the FDA raised in custody of his examination.
“Our room one the priority is to provide babies and families with the high quality formulas they need and this is the main step reopening our Sturgis facility so that we can address the lack of infant formula across the country. We are looking forward work with The Food and Drug Administration (FDA) will quickly and safely reopen the facility,” said Abbott Chairman and CEO Robert B. Ford. in a news release. “We know millions of parents and guardians depend on us and we deeply regret that our voluntary recall has exacerbated the nationwide shortage of infant formula. We will work hard reearn the trust that moms, dads and guardians gave in our formulas for more than 50 years.
In addition, the FDA review of company records found that Abbott discovered the bacteria Cronobacter in batches of ready mixes were produced in 2019 and 2020.
In its preliminary findings, the FDA said Abbott had not established system of process controls covering all stages of pollution prevention treatment of formula with microorganisms and that all surfaces that come into contact with infant formula are kept clean to prevent contamination.
In the end, however, testing by the FDA and US Centers for Disease control and prevention found that genetic sequences of samples of Cronobacter inside the plant are not match Any of bacteria isolated from patients children or a formula inside their homes so there was no link found to the Sturgis facility.
Genetic samples from sick babies also not match each other, suggesting there was no connection between their affairs, Abbott said. in This news release. Cronobacter bacteria usually found in in environment.
Moreover, according to Abbott, no baby formula distributed among consumers has given a positive result for Cronobacteria or salmonella.
“Our safety and quality processes meet even the most stringent requirements, and we are committed to continuous improvement of our processes and protocols,” said Ford. “Nutrition is fundamental to Abbott and our goal of life improvement of more than 3 billion people by the end of the decade. We intend set in standard for industry, raising the bar on both safety and quality.”
Laura Smitherman of CNN contributed to this report.