In September 2021, FDA learned of the potential link between a rare and deadly foodborne pathogen and powdered infant formula manufactured by Abbott Laboratories in a facility in Sturgis, Michigan. This week I received a 34-page report from a whistleblower, a former employee at the plant which produced the contaminated formula – which led to at least 4 hospitalizations and the deaths of at least 2 babies.
The whistleblower report lays out a damning list of allegations of wrongdoing at this factory, including:
* Falsification of records relating to testing of seals, signing verifications without adequate knowledge, failure to maintain accurate maintenance records, shipping packages with fill weights lower than what was on the label, and more;
* Releasing untested infant formula;
* Hiding information during a 2019 FDA audit;
* Lax practices associated with clean in place procedures;
* Lack of traceability of the product;
* Failure to take corrective measures once the company knew their testing procedures were deficient;
* An atmosphere of retaliation against any employee who raised concerns about company practices.
I am equally concerned that the FDA reacted far too slowly to this report. The report was submitted to the FDA on October 20, 2021. The FDA did not interview the whistleblower until late December 2021. According to news reports, FDA did not inspect the plant in person until January 31, 2022, and the recall was not issued until February 17, 2022.
If Abbott cannot guarantee the safety of infant formula purchased through the WIC program, the federal government should not be in business with them. I look forward to working with you on this. https://delauro.house.gov/media-center/press-releases/icymi-delauro-shares-whistleblower-report-contaminated-infant-formulaDeLauro: 4+ Months Between Infant Formula Recall & When FDA First Learned of Potential Danger; Report Shows Falsification of Records, Untested Infant Formula, Hiding Information During 2019 FDA Audit at Abbott Facility; Babies Died | Mining Awareness +