Abbott, FDA Warned For Formula Plant One Year Before Recall

Abbott and the Food and Drug Administration were warned of a whistleblower complaint about Abbott’s Sturgis infant formula plant as early as February 2021, ABC News has confirmed.

This complaint, filed with the U.S. Labor Department’s Occupational Safety and Health Administration, raises quality control concerns at Abbott’s formula plant in Sturgis, Michigan — a year before the mass recall and shutdown of the company in February 2022 over contamination concerns, which helped address a nationwide baby food shortage, according to sources familiar with the case.

OSHA received a whistleblower complaint on Feb. 16, 2021 and sent a copy to the FDA and Abbott three days later, according to a person familiar with the matter.

The complaint raises further questions about when both Abbott and federal health authorities first became aware of the quality and contamination issues at the Sturgis plant, and why it took so long to take action.

The OSHA complaint, first reported by WSJ, alleges problems at the Sturgis factory, such as faulty equipment requiring repair or upgrade and insufficient safety validation for released product.

It was filed months before similar allegations were made in another whistleblower report, which, according to sources familiar with the case, reported contamination issues at the Sturgis plant in October 2021.

The allegations in that October report included “ongoing problems” with the “integrity” of seals on powdered products, that the facility had used “dubious practices” to test whether the issues had been resolved, attempted to circumvent certain oversights, and ignoring quality checks, falsifying data “on a regular and ongoing basis” and causing “dubious practices” regarding equipment cleaning to “proliferate”.

Abbott spokesman Scott Stoffel told ABC News that an internal investigation into the OSHA’s February 2021 complaint “failed to confirm the allegations.”

“We believe this is a former employee who was fired for serious violations of Abbott’s food safety policy,” the company spokesperson added. pattern of ever-evolving, ever-escalating accusations.”

In response to ABC News’ request for comment, an FDA spokesperson acknowledged the changing timeline of events leading up to the FDA’s warning and eventual recall from Abbott, but declined to comment specifically on the OSHA complaint.

“We know there have been several questions about the timeline of events leading up to the FDA’s warning and Abbott’s recall of products manufactured at their Sturgis facility,” said FDA spokesman Michael Felberbaum, adding that the FDA The highest priority right now is the high demand for infant formula in the US market, and our teams are working day and night to make that happen.”

Felberbaum noted that the FDA “can and should do better or faster, and we have initiated a detailed post-action review so that we can make improvements to our programs, processes and decision-making.”

ABC was the first to report that the FDA is now being audited by HHS-OIG for how it responded in the run-up to Abbott’s mass recall — investigating whether the agency was upholding its responsibilities to “protect the country’s food supply” and whether FDA regulators followed the appropriate recall protocol once a deadly bacteria was detected in the plant.

Chris Calamari, Abbott’s senior vice president of U.S. nutrition, has testified under oath that the company was not aware of the October whistleblower complaint until late April 2022, when it was made public.

Stoffel, of Abbott, said there is an “open investigation” into those October allegations that “expand on the federal OSHA allegations” as of February 2021.

Neither the FDA nor Abbott mentioned that they were warned of an OSHA complaint raising concerns about product safety in February 2021 during their testimony in late May this year.

This was not the first time questions had been raised about factory quality control. The FDA found sanitation issues in Sturgis in September 2021, saying the facility “has failed to maintain a building used for manufacturing, processing, packaging or storing infant formula in a clean and hygienic condition,” according to an inspection report. And by Feb. 1, the FDA had collected samples at the plant that confirmed the presence of cronobacter, according to an inspection report. Abbott maintains that there is no conclusive evidence that its products have contributed to the illness or death of infants.

Abbott, the largest infant formula manufacturer in the country, closed its Michigan plant in February 2022, following contamination concerns and a major recall of several of its brands, exacerbating a nationwide infant formula shortage.

In early June, it officially reopened its doors and restarted production after meeting the initial requirements of an agreement with the FDA on how to safely reopen.

“Abbott takes employee concerns very seriously and we foster a culture of compliance to produce the best and highest quality products,” said Stoffel. “We enable our employees to identify and report any issues that could compromise the safety or quality of our products, which takes precedence over other considerations.”

Anne Flaherty and Kaitlyn Folmer of ABC News contributed to this report.

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