The FDA entered into a consent decree with Abbott (NYSE:ABT) to reopen its troubled Sturgis, Mich., baby formula plant even though the agency "lost confidence" in the company's safety and quality culture, as well as commitment to fix problems quickly.
In testimony before a House subcommittee Wednesday, FDA Commissioner Robert Califf and others said that a consent decree was pursued rather than a permanent injunction given Abbott's market share for baby formula.
"A consent decree was the best option, giving FDA more control over the outcome, and was more likely to result in a safe resumption of operations by Abbott Nutrition at the Sturgis facility," the testimony stated.
FDA tests for Cronobacter bacteria in finished product from the plant tested negative, though the agency added such tests are not likely to detect low levels of contamination. However, the FDA said five environmental surface swabs collected at the plant did test positive.
Califf told the committee that inspections of facility found cracks in equipment, a leaky roof, standing water, and bacteria growing in multiple places, CNBC reported.
"This is so far removed from my previous experience with the company that I am concerned," he added.
Califf said he spoke with Abbott (ABT) CEO Robert Ford on Tuesday who assured him the Sturgis facility would be up and running in early June.
The Washington Post on Wednesday reported that a whistleblower report on the conditions in the Sturgis plant took months to get to a top FDA official.