NYT Times Reports: Infant Formula Company Tied to Botulism Outbreak Had Known Problems

The New York Times reported this afternoon:

A Pennsylvania plant run by the company, ByHeart, was shut down this year after inspectors found mold, a leaking roof and more than 2,500 dead insects in a food production area.

ByHeart, the company linked to a botulism outbreak in infants, shut down one of its manufacturing plants this year after federal investigators found a series of safety violations, including a leaking roof and hundreds of dead bugs where infant formula was produced.

Inspection reports by the Food and Drug Administration detailed significant problems at the company’s site in Reading, Pa. 

Months later, F.D.A. inspectors returned to the Pennsylvania manufacturing site, detecting mold in a tank meant to contain clean water, finding more than 2,700 dead insects in a food production area and learning the plant had dealt with several roof leaks. The F.D.A. classified the inspection at its highest tier of concern.

Now the F.D.A. is investigating the company’s facilities in Allerton, Iowa, and Portland, Ore., which produced the formula that was widely recalled from supermarket shelves. 

The agency’s warning letter outlined events from July through August 2022, when the company’s contract laboratory discovered cronobacter sakazakii, in its processing area. These were the same bacteria that set off alarms at the Abbott plant.

By mid-October, ByHeart learned that the same bacteria had been found in its finished product, according to the agency. The bacteria are common in dirt and in kitchen sinks, but infant formula manufacturers are held to high standards to keep their products clean.

F.D.A. inspectors returned to the Pennsylvania plant in December 2023 and found more problems.

The Pennsylvania facility had a leaking roof, which was described to F.D.A. inspectors as a roof built in five sections. The age of the roofing could not be determined by facility managers or the roofing company, the inspection report said.

At that plant, the agency also found that ByHeart failed to protect its formula against contamination from pests, with an inspector noting on Dec. 11, 2023, that flies were buzzing overhead in a sensitive area of formula production. In the same area, the inspector observed more than 2,500 dead flying bugs near three insect light traps.

The plant also violated its rules for maintaining temperatures needed to eliminate bacteria from the formula before it was shipped for packaging, the report said. Variations in temperature should have prompted a report to a supervisor, but no notification occurred, and the formula went out to customers.

The Portland facility inspections note no official concerns from the F.D.A.

In June 2022, agency inspectors at the company’s plant in Iowa swabbed the production area and found cronobacter sakazakii near the milk dryer. Inspectors pointed out “microcracks” on equipment used to dry milk, saying they could harbor bacteria and urging the company to fix them.

Thanks to:

Christina Jewett covers the Food and Drug Administration, which means keeping a close eye on drugs, medical devices, food safety and tobacco policy.

Julie Creswell is a business reporter covering the food industry for The Times, writing about all aspects of food, including farming, food inflation, supply-chain disruptions and climate change.

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.

Source: https://www.marlerblog.com/case-news/nyt-times-reports-infant-formula-company-tied-to-botulism-outbreak-had-known-problems/