U.S. FDA defends baby formula shortage response in Congress -Breaking
WASHINGTON, (Reuters) – The U.S. Food and Drug Administration testified Wednesday before Congress to defend the actions it took in response to concerns about baby formula contamination. Abbott Laboratories Plant that was closed in February
FDA representatives will be appearing before a congressional committee to address questions regarding one of the most severe infant formula shortages in American history. This is after Abbott closed down its Sturgis, Michigan manufacturing plant and recalled certain products in February.
Because the Sturgis plant is the third run by Abbott and has the highest U.S. infant formula market share, it was essential to be online immediately. They also stated that Abbott didn’t have any contingency plans to make its line of specialty formulas which are the sole source of nutrition for thousands upon thousands of children with metabolic disorder.
The agency agreed to a consent decree with Abbott in order to expedite the process. This agreement allows company to avoid legal action by promising to take voluntary measures to improve and correct deficiencies while under the supervision of FDA officials.
In testimony before U.S. House of Representatives Commerce and Energy Subcommittee of Oversight and Investigations, Dr. Robert Califf stated that the FDA had to approve the consent decree after inspecting the Sturgis facility.
Abbott stated Tuesday that the company planned to reopen its plant in June.