F.D.A. Chief Details ‘Shocking’ Conditions at Baby Formula Plant

The Abbott Nutrition plant in Michigan that was shut down in February, sparking a widespread baby formula shortage crisis, had a leaking roof, water pooled on the floor and cracks in key production equipment that allowed bacteria to get in and persist, Dr. Robert Califf, the head of the Food and Drug Administration, told a House panel on Wednesday.

He detailed “egregiously unsanitary” conditions in the Sturgis, Mich., plant to lawmakers during a hearing, but he also acknowledged that his agency’s response was too slow in addressing problems at the plant.

“Frankly, the inspection results were shocking,” Dr. Califf told members of the House Energy and Commerce Subcommittee on Oversight and Investigations. “We had no confidence in integrity of the quality program at the facility,” noting the agency worked with Justice Department officials to dictate steps the company needed to take to turn the facility around.

That effort is expected to result in the plant reopening on June 4, Jonathon Hamilton, an Abbott spokesman, said, with some formula expected to begin rolling out June 20. Officials hope new shipments will reach store shelves within six to eight weeks, although resumption of full production at the plant will take longer.