Legal Insurrection by Mary Chastain June 18, 2024
“Had [the] FDA initiated the Abbott facility inspection sooner, [the] FDA may have identified the issues at the Abbott facility and recommended that Abbott recall products sooner.”The Department of Health and Human Services’ Office of Inspector General (OIG) discovered the FDA waited 15 months to respond to a complaint about the conditions at an Abbott Nutrition facility.
Those conditions led to a nationwide formula shortage in 2022.
The whistleblower claimed employees cut corners:
For instance, according to the complaint, the employee reported observing events that were understated or inaccurately described “to limit or avoid oversight” and then “failing to maintain accurate maintenance records.”
After several samples of a batch of infant formula were found to contain microorganisms, or “micros,” the whistleblower claims that the plant performed a time code removal, in which formula produced around the same time as the contaminated samples was discarded, but formula produced outside of those time codes was released to be sold without additional testing to make sure it was safe for consumption.
In 2020, the complaint says, product wasn’t recalled from the market even after management became aware of a problem with the integrity of the packaging, an issue that the whistleblower said should have caused the manufacturer to take the product off shelves and conduct more testing.
The tainted formula caused the death of two infants, and several landed in the hospital.
The OIG also found that the FDA doesn’t have policies to identify problems with the formula.
More:
https://legalinsurrection.com/2024/06/fda-waited-15-months-to-investigate-complaints-about-baby-formula-plant/
