A whistleblower at the Abbott Nutrition formula plant in Sturgis, Michigan, warned FDA officials about "lax practices, including regulatory violations" months before a second infant died after consuming Similac powdered baby formula, reports Politico.
Abbott Nutrition voluntarily recalled certain powdered baby formulas on Monday after learning that the infant who consumed Similac tested positive for Cronobacter sakazakii, a rare but dangerous bacteria that can cause blood infections and other serious complications.
The FDA in mid-February warned parents not to use three popular powdered infant formulas, certain lots of Similac, Alimentum, and EleCare with expiration dates of April 1, 2022, or later — manufactured at an Abbott plant in Sturgis due to possible bacterial contamination.
FDA officials said five infants had to be hospitalized after using the formula — four tested positive for Cronobacter and one for salmonella.
The whistleblower in mid-October warned the FDA that officials at the Sturgis plant purposely falsified records to keep the agency from learning about serious issues related to the plant's system for checking for bacteria in formula. The person also outlined allegations of lax cleaning practices.
Hard copies of the complaint were sent via FedEx to senior FDA officials, including then-acting Commissioner Janet Woodcock, Susan Mayne, director of the Center for Food Safety and Applied Nutrition, Judy McMeekin, associate commissioner for Regulatory Affairs and Catherine Hermsen, assistant commissioner of the agency's Office of Criminal Investigations.
Rep. Rosa DeLauro, D-Conn., on Thursday revealed the whistleblower document.
"I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility," DeLauro said. "I am equally concerned that the FDA reacted far too slowly to this report."
She said the FDA didn't interview the whistleblower until December and did not inspect the plant until Jan. 31.