‘A movie set’: Former supervisor at baby formula plant says flaws were hidden

August 4, 2022 Off By administrator

“The plant would prep heavily before audits,” the former supervisor said. “The plant basically turned into a movie set where only things the higher ups wanted the FDA to see were seen.”

The revelations come after the plant reopened for production July 1. The plant had been shut down from February to June after the FDA found insanitary conditions in the plant. The plant briefly re-opened then shut down again after a severe storm in mid-June left the plant partially flooded.

Despite the plant reopening and a Biden administration effort to fly formula in from Europe and Australia since May, retail stocks of infant formula have worsened and it’s still common for parents to see shelves that are sparse — five months after reports of infant hospitalizations and deaths sparked a massive recall of Abbott Nutrition products.

Abbott disputed the former employee’s characterization of the plant.

“The claims made by this unnamed source … are either inaccurate or completely taken out of context,” said Scott Stoffel, divisional vice president of external communications and public affairs at Abbott.

Stoffel said that without knowing the identity of the person making the claims it was impossible to verify their employment, what they had knowledge of or the circumstances under which they left the plant.

The FDA, asked to explain why problems were not caught earlier, contended that inspections are just one part of food safety oversight and that ultimately it’s up to manufacturers to assure the safety of their products every day.

“We take seriously our duty to prevent and respond to foodborne illnesses and food contamination events,” an FDA spokesperson said.

Lawmakers on both sides of the aisle have raised questions about the FDA’s handling of the incident, as questions remain about why federal regulators didn’t take action sooner.

After months of investigation, the FDA has said it cannot definitively link the hospitalizations and deaths to the formula plant, nor can it rule out a link. The agency found five strains of Cronobacter in the plant in early 2022, but none of the strains have matched the limited samples the government has to compare them to. One huge challenge for investigators is that Cronobacter sakazakii, the bacteria to blame, is not a reportable condition, which means that illnesses are not routinely reported to the CDC’s public health monitoring system. This means federal officials lack much of the evidence they’d normally have for an investigation like this.

Still, FDA Commissioner Robert Califf in May blasted the plant for having “egregiously unsanitary” conditions.

“Frankly, the inspection results were shocking,” Califf told lawmakers before a House Energy and Commerce subcommittee hearing on the infant formula debacle — a hearing that repeatedly drew on POLITICO’s reporting on the infant formula timeline as well as broader dysfunction within FDA’s food program.

The former supervisor,…

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