FDA: Another infant death likely linked to Abbott formula

According to press reports, the U.S. Food and Drug Administration said on Wednesday it was notified of one more infant death in January potentially related to Abbott Laboratories’ baby formula and the agency has started a probe.

Abbott initiated a recall of its infant formula products and closed its Michigan plant in February after reports of serious bacterial infections in four infants, worsening a shortage among multiple manufacturers that began with pandemic supply chain issues.

The date of death and state of death was not announced. The FDA apparently became aware of the death on June 10, 2020. So far, the FDA has received 129 complaints linked to Abbott formula products, including 119 since the product recall in February.

According to the FDA, this would bring the total to five illnesses with three deaths.

Total Adverse Events: 5
Hospitalizations: 5
Reported Deaths: 3
Illness Onset Date Range: 9/6/2021 – 1/4/2022
States with Adverse Events: MN (1), OH (2), TX (1)
Product Distribution: Nationwide and International

The facility is now set to reopen, but not before the U.S. Attorney sued Abbott and several employees. In the complaint, filed by the U.S. Department of Justice on behalf of the FDA, the government alleges that powdered infant formula products manufactured at Abbott Nutrition’s Sturgis facility were adulterated because they were made under insanitary conditions and in violation of current good manufacturing practice requirements.

Abbott is essentially confessing to the violations in the below consent decree. Under the proposed consent decree, Abbott Nutrition will be required to retain an independent expert to review the Sturgis facility’s operations to ensure compliance with the law. It also includes requirements for testing products, as well as ceasing production, and promptly notifying the FDA should contamination be detected. The proposed consent decree also requires the implementation of a sanitation plan, environmental monitoring plan and employee training programs.

Here are the key documents:

Here is the 2021 inspection report at the plant – APPLIED – FOI II – BR Abbott Nutritions- FEI# 1815692 9-2021 EIR.

Here are the whistleblower documents – Redacted Confidential Disclosure re Abbott Laboratories – 10-19-2021_Redacted (1)

Here is the 2022 inspection report at the plant – Updated Final Applied_Unapplied Redactions Abbott Nutrition Sturgis FEI 1815692 FDA 483 1-31022 to 3-16-22 – ISSUED_Redacted

Here is the complaint – abbott_complaint_0

Here is the consent decree – abbott_proposed_consent_decree_0

Please read the above and ask the question: is this how infant formula should have been manufactured?

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