As Americans experience an acute shortage of baby formula driven by recent recalls of contaminated Abbott Laboratories products and the shutdown of its formula plant in Sturgis, MI, members of Congress and the House of Representatives on both sides of the aisle are asking for answers and calling out federal food safety regulators for responding slowly to a whistleblower complaint alleging wrongdoing at the Michigan facility.
A 34-page whistleblower report authored by a former employee at Abbott’s Sturgis plant was sent to the US Food and Drug Administration (FDA) in October 2021, claiming that the company falsified records, hid information from investigators during a 2019 audit of the plant by the FDA, maintained lax clean-in-place (CIP) procedures, failed to take corrective measures, and released untested infant formula. Other allegations included lacking traceability of the product and an atmosphere of retaliation.
House Appropriations Committee Chair Rose DeLaura (D-CT) released details
of the document in late April, expressing concern in a statement that the “FDA reacted too far too slowly” on the allegations.
“The report was submitted to FDA on Oct. 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 Jan. 31, 2022, and the recall was not issued until Feb. 17, 2022,” Rep. DeLaura said in a release. “Why did the FDA not spring into action? Why did it take four months...
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