Tuesday, May 17, 2022

Abbott reaches agreement with FDA to reopen formula plant

Abbott Laboratories "reached an agreement with the Food and Drug Administration on Monday to reopen the company’s manufacturing plant in Michigan to help ease a nationwide shortage of baby formula, after the facility was closed due to bacterial contamination," reports Spencer Kimball of CNBC. According to the consent decree, Abbott can resume production at its plant in Sturgis, Michigan, within two weeks once the FDA signs off on it, but it will take six to eight weeks after production resumes for formula to hit store shelves.

The FDA ordered the Abbott plant to shut down in February after four infants were sickened from contaminated formula and two died. 

"Under the consent decree to reopen the plant, Abbott has agreed to bring in outside experts to help the facility come into compliance with food safety regulations, according to the Justice Department," Kimball reports. "The outside experts will design a plan for Abbott to reduce the risk of bacterial contamination at the plant and conduct periodic evaluations to make sure the company is in compliance. The process will be under FDA supervision."

In the meantime, the FDA will allow some imported formula meant for foreign markets to enter the U.S., but only after the agency has evaluated whether each manufacturer that applies has a safe and nutritious product. The FDA has been allowing more formula imports meant for the U.S. since February, Kimball reports.

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