Abbott reaches agreement with FDA to resume production of baby formula | GAMEJES

Abbott reaches agreement with FDA to resume production of baby formula

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 lays out the required steps to safely restart production and maintain the site in Sturgis. It is subject to court approval.

“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 Chief Executive Robert Ford said in a statement. “We look forward to working with the FDA to quickly and safely re-open the facility.”

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.

Later on Monday, the Justice Department filed a complaint and proposed 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.”

The decree 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 FDA Commissioner Robert 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 January.

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.

Abbott baby formula lab could reopen ‘very soon,’ FDA Chief says

May 16, 202204:23

Califf on Monday rejected the prediction made by the CEO of formula maker Perrigo that the nationwide shortage will last through the end of the year, saying that the FDA is taking a number of measures to increase production and could move to import products. The U.S. does not import baby formula from abroad, but Califf said there could be an announcement about a change in that policy on Monday.

“Remember that formula intended for other countries may be labeled in a language which is not the language that is needed for the instructions for mothers and other caretakers to mix up the formula,” Califf said. He added that the FDA has to test the formula to ensure it’s safe and contains the correct ingredients. “But I really expect by the end of the day, we’ll have an announcement on that path forward,” he said.

A White House official said Monday that it 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.”

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 lays out the required steps to safely restart production and maintain the site in Sturgis. It is subject to court approval.

“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 Chief Executive Robert Ford said in a statement. “We look forward to working with the FDA to quickly and safely re-open the facility.”

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.

Later on Monday, the Justice Department filed a complaint and proposed 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.”

The decree 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 FDA Commissioner Robert 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 January.

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.

Abbott baby formula lab could reopen ‘very soon,’ FDA Chief says

May 16, 202204:23

Califf on Monday rejected the prediction made by the CEO of formula maker Perrigo that the nationwide shortage will last through the end of the year, saying that the FDA is taking a number of measures to increase production and could move to import products. The U.S. does not import baby formula from abroad, but Califf said there could be an announcement about a change in that policy on Monday.

“Remember that formula intended for other countries may be labeled in a language which is not the language that is needed for the instructions for mothers and other caretakers to mix up the formula,” Califf said. He added that the FDA has to test the formula to ensure it’s safe and contains the correct ingredients. “But I really expect by the end of the day, we’ll have an announcement on that path forward,” he said.

A White House official said Monday that it 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.”

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