Abbott Enters Into Consent Decree With U.S. FDA to Restart Production At Infant Formula Plant In Sturgis, MI

After its abrupt closure in February due to contamination concerns, the Abbot Formula Plant in Sturgis, Michigan has now entered into the Consent Decree with the FDA in order to re-open as early as two weeks from today. This site closure has severly exacerbated the nationwide formula shortage..In mid February, consumers reported four infants who were sick, including three with Cronobacter sakazakii infections and one with Salmonella newport, and had been fed formula products made at the Sturgis plant. A fourth infant with cronobacter sakazakii was later added to the investigation by the U.S. Centers for Disease and Control Prevention. The CDC began its investigation and a recall began in mid-February with dozens of types of Similac, Alimentum and EleCare powdered formulas. A specialty liquid formula called Similac PM 60/40 was added to the recall at the end of February. The CDC found that Cronobacter sakazakii was active within the plant, but not in samples tested, which shut down the factory..So, now Abbot has entered into a Consent Decree which is an agreement between a company and the federal government which says the party in fault (Abbott) has taken steps to assuage the concerns of the government and can continue normal operations..Abbot had this to say in a press release moments ago concerning the CDC findings:."After a thorough investigation by FDA, Centers for Disease Control and Prevention (CDC) and Abbott, and review of all available data, there is no conclusive evidence to link Abbott's formulas to these infant illnesses. Specifically:.CDC concluded its investigation with no findings of a link between Abbott formulas and infant illnesses.Abbott conducts microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakiior Salmonella.All retained product tested by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter sakazakii 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.Genetic sequencing on the two available samples from ill infants did not match the strains of Cronobacter sakazakii found in our plant. Samples from ill infants did not match each other, which means 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.".Abbott also had this to say concerning the mitigating steps it has taken since the closure to lighten the burden on American families in need of formula:."Since the recall, the company has taken numerous measures to mitigate the supply shortage. Specifically, it has focused on production in its Cootehill, Ireland, facility to serve state Special Supplemental Nutrition Program for Women, Infants and Children (WIC) consumers..Abbott has been working with the U.S. Department of Agriculture (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 Friday it will continue to pay rebates for competitive products through August 31. This means program participants will continue to be able to obtain formula free of charge, whether it is Similac or formula from another manufacturer. Additionally, the company has:.Air shipped millions of cans of infant formula powder into the U.S. from our FDA-registered facility in Cootehill, Ireland.Prioritized infant formula production at our Columbus, Ohio, facility, converting other liquid manufacturing lines into manufacturing Similac liquid ready-to-feed and ramped production at our other U.S. manufacturing site in Casa Grande, Arizona, for powder infant formula.Offered an increased number and value of coupons available for all infant formula products, including Similac liquid ready-to-feed, to enable customers to purchase formula, either free or deeply discounted.Been running other facilities at full capacity to help replenish the supply in the market.".Once the FDA confirms the initial requirements for start-up have been met, Abbott could restart the site within two weeks. The company would begin production of EleCare®, Alimentum® and metabolic formulas first and then begin production of Similac® and other formulas. From the time Abbott restarts the site, it will take six to eight weeks before product is available on shelves. Last year Abbott produced 42% of America's infant formula. The only reason why the shortage is not worse is because Abbott also produced formula in Ireland, where they have increased production rates to import back to the U.S. The plant is Sturgis is one of five plants Abbot operates, so its closure probably decreased production by 20%, of the 42% that Americans rely on.