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FDA Reaches Agreement to Reopen Baby Formula Plant

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Food and Drug Admnistration | Shutterstock

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On Monday, the Food and Drug Administration (FDA) reached an agreement with Abbott Foods to reopen the Sturgis, Michigan, plant that underwent a voluntary shutdown in February.

The plant, a major manufacturer of various types of Similac formula, had voluntarily closed after four infants became ill, two of whom passed away. After shutting down in February, Abbott had the facility tested for the presence of the bacteria (cronobacter) that caused the infants’ illnesses.

Abbott tweeted a correction late last week after former White House Press Secretary Jen Psaki said the company’s products had been instrumental in four cases of illness. Abbott noted that no traces of the bacteria were found in its plant.

Abbott also asked why the FDA had not done its part to get the plant back open. On Monday, the FDA released a statement that the initial requirements to reopen the plant had been met. The FDA says the site could resume production within two weeks.

Robert Ford, the chief executive officer at Abbott, expressed excitement at the potential restart of the plant: “This is a major step in reopening our Sturgis facility so we can ease the nationwide formula shortage. We look forward to working with the FDA to quickly and safely reopen the facility.”

Abbott is the largest U.S. supplier of milk formula, contributing to the formula shortage across the country. Many retailers have been forced to limit quantities sold if they can get baby formula.

The agreement between Abbott and the FDA, known as a consent decree, is subject to court approval. One of its requirements stipulates that Abbott must retain an independent expert to review the facility’s operations to ensure compliance. Abbott must also take corrective action, although the FDA has not laid out what all that entails.

However, Abbott will need to commit to a sanitation plan and an environmental monitoring plan. Employees will have to participate in training programs, and products will be randomly tested. Should any contamination be found in the facility, Abbott must notify the FDA immediately and cease production.

Abbott is also expected to pay “one-time specified charges for expenses related to the consent decree.”

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