According to ABCNews.go.com, the U.S. Food and Drug Administration and Abbott were warned about the Abbott’s Sturgis infant formula plant back in February 2021, a whistleblower complaint alleges. The whistleblower complaint, which has been filed with the U.S. Labor Department’s Occupational Safety and Health Administration, states that the quality control issues at Abbott’s formula plant […]
According to ABCNews.go.com, the U.S. Food and Drug Administration and Abbott were warned about the Abbott’s Sturgis infant formula plant back in February 2021, a whistleblower complaint alleges. The whistleblower complaint, which has been filed with the U.S. Labor Department’s Occupational Safety and Health Administration, states that the quality control issues at Abbott’s formula plant in Sturgis, Michigan, were known one year before the massive baby formula recall. The recall created a national shortage of baby formula. The Occupational Safety and Health Administration received the whistleblower complaint on February 16, 2021. A copy of the complaint was sent to the FDA and Abbott three days after OSHA received the complaint.
The whistleblower complaint now raises more questions about when federal health authorities and Abbott first knew about the Sturgis plant contamination concerns and why the recall took so long to initiate.
The OSHA complaint alleged that the Sturgis plant had faulty equipment needing repairs and insufficient safety validation for the finished products. The complaint was filed several months before identical allegations were made in a separate whistleblower complaint, which raised contamination fears at the Sturgis plant last October. The allegations asserted in the October report included defective seals on powdered products, questionable test practices, efforts to evade some oversight and override quality checks, questionable practices related to the cleaning of equipment, and falsified records.
Scott Stoffel, an Abbott spokesperson, stated that an internal investigation stemming from the February 2021 OSHA whistleblower complaint had not confirmed the allegations. The spokesperson stated that a former employee who was fired may have been responsible for the violations of Abbott’s food safety policies.
FDA spokesperson, Michael Felberbaum, stated that there had been many questions about the timeline of events at their Sturgis facility. ABC was the first news agency to report that the FDA is now being audited by HHS-OIG. The agency is probing whether or not the FDA upheld its responsibilities to “safeguard the nation’s food supply” and determine if the FDA followed proper recall protocols after a deadly bacteria was found inside the Sturgis plant.
According to the news report, the FDA and Abbott stated in testimony provided in May that they had been alerted to the OSHA complaint’s product safety concerns in February 2021. One year before the recall was initiated. The FDA also found sanitation problems at the Sturgis plant back in September 2021. The FDA stated in that report that the facility “did not maintain a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition.” On February 1, the FDA collected samples at the Sturgis plant, and the test results found the presence of cronobacter sakazakii.
Abbott is the largest infant formula manufacturer in the country. It shut down its Sturgis plant in February 2022. In June, Abbott officially reopened and restarted production after passing FDA inspections.
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