Abbott Laboratories has reportedly entered an agreement with the FDA (Food and Drug Administration).
This agreement will enable Abbott to reinstate its manufacturing facility in Michigan and ease a nationwide dearth of baby formula.
The facility was previously shut down due to bacterial contamination. According to FDA Commissioner Robert Califf, Abbott will comply with the conditions of the agreement and improve the sanitary conditions that resulted in the contamination and the shutdown.
Califf added that the company’s baby formulas will cater to the quality and safety standards of the agency.
The agreement between the FDA and Abbott, dubbed the consent decree, received approval from the U.S. District Court for the Western District of Michigan.
Under this decree, Abbott will bring in outside experts to aid the plant in aligning with food safety regulations. These experts will devise a plan for the Illinois-based company to curb the possibility of causing bacterial contamination at the facility. The experts will also perform periodic assessments to ensure the company’s compliance with the regulations.
Abbott can restart the Michigan facility within two weeks. But the company cited that it would take 6 to 8 weeks to get the new batches of formula on store shelves.
The United States is witnessing a major shortage of baby formula. Close to 40% of the baby formula was out of stock throughout the nation during the first week of May.
The supply shortage was partly triggered by the closure of Abbot’s Michigan facility after four infants fell ill after consuming formula produced at the plant. Two of the infants lost their lives. It should be noted that Abbott is America’s largest manufacturer of infant formula.
In a complaint filed by the FDA, the Justice Department alleged that products manufactured at the company’s Michigan plant were impure because they were produced under insanitary conditions.
Further FDA inspections found that the factory contained Cronobacter sakazakiim, a bacteria that causes blood infection. According to the agency, the internal company records showed that it destroyed some of its products owing to the presence of bacteria at the facility.
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