Agreement between Abbott and the court to restart the plant

Millions of parents breathe. The US-based Abbott group has reached an agreement with the justice system to restart production of baby milk at its Michigan facility to alleviate shortages of this vital infant product, the group and the US Department of Justice announced on Monday. The United States is experiencing a very rare shortage of baby milk that worries millions of parents.

Initially fueled by supply chain problems and labor shortages due to the pandemic, the shortage worsened when Abbott’s Michigan plant closed in February following a product recall that allegedly killed two babies.

The US Food and Drug Administration (FDA) approved the milk but found “483 violations” at the factory, Abbott said Friday, stressing that it “immediately began implementing corrective actions.”

The Justice Department and Abbott said in a separate statement that the deal still needs to be approved by a judge. But the manufacturer, one of the main players in the baby milk market, plans to reopen its Michigan plant within two weeks. He reiterated that it would then take “6 to 8 weeks before products hit the shelves.”

Milk from abroad

Until then, the company will continue to import baby milk from its factory in Ireland to try to reduce shortages in the United States. In a separate statement, FDA chief Robert Kaliff said the agreement means Abbott “agreed to address certain issues identified by the agency at its manufacturing facility.”

He added that his services are looking at available supplies from manufacturers in the United States and around the world “to determine if their distribution can be redeployed to get the right product to the right place at the right time.”

Robert Kaliff also announced a little later that the FDA intends to look into distribution applications from international baby milk manufacturers that do not normally distribute their products in the United States.

50% out of stock

A senior White House official said the fast-track approval process will favor those who demonstrate “clear compliance in terms of quality, safety and nutrition” with US standards.

According to the FDA boss, baby milk produced abroad could be on the shelves within a few weeks. The United States currently produces 98% of the baby milk consumed in the country.

Datasembly, a data provider, reported on May 10 that by the end of last week, infant formula out of stock had reached 43%. Then in some regions of the country it exceeded 50%.

The White House is in constant contact with the four major manufacturers Reckitt, Abbott, Nestlé/Gerber and Perrigo to identify transportation, logistics and sourcing roadblocks to increase production (…) and ensure faster delivery of products to retailers, the official said.

The Biden administration is also in “constant communication” with major retailers such as Target, Amazon and Walmart “to identify areas of the country that could pose a critical supply risk,” according to the same source.