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Abbott reaches agreement with FDA to resume production of baby formula

The Food and Drug Administration also announced guidelines that would boost imports of formula from abroad.

WASHINGTON — Abbott Nutrition said Monday it has agreed to terms set by the Food and Drug Administration to resume operations at the company's Michigan plant amid a nationwide shortage of baby formula.

The consent decree, which requires court approval, lays out the required steps to safely restart production and maintain the site in Sturgis.

"Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage," Abbott CEO Robert Ford said in a statement. "We look forward to working with the FDA to quickly and safely re-open the facility."

Under the agreement, the Sturgis facility will be required to retain an independent expert to review operations and ensure that it follows the law. The decree also includes measures for testing products and halting production in the event of contamination.

After the FDA confirms Abbott has met initial requirements, the company could restart the site within two weeks. Abbott said it will take another six to eight weeks for product to reach store shelves.

“Today’s action means that Abbott Nutrition has agreed to address certain issues that the agency identified at their infant formula production facility in Michigan,” FDA Commissioner Robert Califf said in a statement. “The public should rest assured that the agency will do everything possible to continue ensuring that infant and other specialty formulas produced by the company meet the FDA’s safety and quality standards, which American consumers have come to expect and deserve."

Later on Monday, the Justice Department filed a complaint and proposed a consent decree to ensure the safety of the plant’s infant formula. According to a Justice Department news release, the complaint alleges the company had operated its Michigan facility “under conditions and using practices that failed to comply with regulations designed to ensure the quality and safety of infant formula, including protection against the risk of contamination from bacteria."

When reached for comment, an Abbott spokesperson referred NBC News to a previous company statement that denied any wrongdoing.

The consent decree proposed by the Justice Department would direct Abbott to step up safety measures and ensure adherence to federal statutes and FDA guidelines for manufacturing.

"The actions we are announcing today will help to safely increase the supply of baby formula for families,” Attorney General Merrick Garland said in a statement.

The announcements came just hours after Califf said his agency will investigate why it took so long to dispatch inspectors to the Michigan plant. A detailed whistleblower report about alleged safety lapses at the plant came out in October, but the FDA didn’t send inspectors to the facility until the end of January.

The FDA said that during an inspection of the Abbott facility that began on Jan. 31, it observed “significant operational deficiencies” and found a bacterium that can potentially trigger severe foodborne illness in babies.

In an interview with Califf on NBC’s “Today” show Monday, anchor Savannah Guthrie said the agency received the first report in September about a sick baby whose infection was allegedly linked to baby formula produced at the plant. Asked if the FDA was too slow to respond, Califf said, "We always want to be as fast as we can possibly be while also being diligent, remembering, as shown by this example, that if we didn't close the plant, then we have a supply shortage, so we have to get this right."

He continued, "There will be a full investigation of the timeline, and we'll do everything possible to correct any errors in timing that we had so that we don't repeat any mistakes that may have been made."

The Biden administration has come under fire for the formula shortage, which has worsened since the Abbott plant in Michigan was shut down in February. The FDA investigated the facility after four infants who drank its formula contracted bacterial infections and became hospitalized. The infections may have also contributed to the deaths of two babies, the agency said.

Abbott has said that it conducted a thorough review and found “no evidence” linking their baby formulas to the illnesses.

The FDA on Monday also announced guidance on "increased flexibilities" for importation. The revised guidance would allow manufacturers who don’t normally distribute baby formula in the U.S. to do so in order to boost availability.

"Companies seeking to take advantage of these flexibilities should submit information for the FDA to quickly evaluate whether the product can be used safely and whether it provides adequate nutrition," the agency said in a statement.

A senior administration official told reporters on a call Monday evening the FDA would prioritize reviewing applications that “stand a good chance of being successful” and are in a position to deliver the most formula as quickly as possible.

Countries that have "health and safety inspection systems similar to our own," such as Australia, New Zealand and the United Kingdom, could soon provide formula, another senior administration official said.

A White House official said earlier Monday that the administration has been in touch with the four major infant formula manufacturers "to identify transportation, logistical, and supplier hurdles to increasing production of formula at their U.S. and FDA-approved facilities, to expand the amount and speed of FDA approved formula being shipped into the country, and ensure that formula is quickly moving to retailers from factories."

The official also said the administration is talking to Amazon, Target and Walmart to identify areas of the country where there are critically low supplies and work with retailers and formula producers to bring the products to those regions.