Baby formula maker Abbott to families experiencing shortages: "We let you down"

• "We are deeply sorry and are committed to making sure that a shortage like this never happens again," Calamari says in prepared testimony for his appearance before a congressional committee.
• "As we move forward, we know that we must work to re-earn the trust that parents and caregivers have placed in our formulas for decades," Calamari says. "It will take time, but we can assure you all that more supply is on the way."

Yes, but: Calamari said that "we continue to believe that there is no conclusive evidence to link our formulas" to infant illnesses and deaths blamed on Cronobacter sakazakii, which was found in an area of Abbott's plant in Sturgis, Michigan, that Abbott says did not come into contact with the formula.

• The FDA promptly shut down the facility following the February recall that exacerbated ongoing supply chain issues for the formula industry.

Worth noting: The FDA disclosed Wednesday in prepared testimony that it learned on Sept. 20 of a Cronobacter infection in an infant who consumed formula made at the Abbott plant. But the agency says it did not discover the pathogen in the product after testing was completed.

• After another case was reported on Dec. 1, FDA set an inspection for Dec. 30 but ended up delaying it for a month after Abbott notified the agency of a dozen COVID-19 cases among its employees.

• Once they completed their inspection, FDA investigators found "serious cracks" in key equipment; "water leaks and condensation, which are risk factors for Cronobacter, in areas where dry powdered formula was produced"; and inadequate hand-washing.

What's next: The FDA is expected to allow Abbott to reopen the factory during the first week of June after the company made a round of improvements.

• "We have been implementing corrective actions and enhancements at the facility and strengthening our existing processes," including "installing non-porous, easily cleanable sanitary floors" and "increasing our finished product testing," Calamari said.