Abbott and the FDA were notified of a whistleblower complaint about Abbott’s Sturgis infant formula plant as early as February 2021.

According to sources familiar with the matter, this complaint, filed with the U.S. Labor Department’s Occupational Safety and Health Administration, alleges quality control issues at Abbott’s formula plant in Sturgis, Michigan, a year before the company’s massive recall and shutdown in February 2022 due to contamination concerns, which exacerbated a nationwide shortage of baby formula.

According to a person familiar with the situation, OSHA received a complaint from a whistleblower on February 16, 2021, and sent a copy three days later to the FDA and Abbott. The complaint raises additional questions about when Abbott and federal health authorities first became aware of quality and contamination concerns at the Sturgis plant, and why it took so long to take action.

According to the OSHA complaint, which was first reported by the WSJ, problems at the Sturgis plant include faulty equipment that needs to be repaired or upgraded, as well as inadequate safety validation for released product.

According to sources familiar with the matter, it was filed several months before similar allegations were made in another whistleblower report, which flagged contamination concerns at the Sturgis plant in October 2021.

According to the October report, the facility had “ongoing problems” with the “integrity” of seals on powdered products, used “questionable practices” to test whether the issues had been fixed, made efforts to evade certain oversight and override quality checks, falsified records “on a regular and ongoing basis,” and allowed “questionable practices” related to equipment cleaning to “proliferate.”

According to Abbott spokesperson Scott Stoffel, an internal investigation into the February 2021 OSHA complaint “has not been able to confirm the allegations.”

“We believe this to be a former employee who was dismissed due to serious violations of Abbott’s food safety policies,” the company spokesperson added, saying the employee had never raised product safety concerns while with the company — and that these complaints continue “a pattern of ever-evolving, ever-escalating allegations.”

The FDA “can and must do better or be faster,” according to Felberbaum, and “we’ve initiated a detailed after-action review so that we can make improvements to our programs, processes, and decision-making.”

The FDA is now being audited by HHS-OIG for how it responded in the lead-up to Abbott’s massive recall, with the agency looking into whether the agency upheld its responsibilities to “safeguard the nation’s food supply” and whether FDA regulators followed proper recall protocol once a deadly bacteria was detected inside the plant.

Abbott’s Senior Vice President for US Nutrition, Chris Calamari, testified under oath that the company was unaware of the October whistleblower complaint until late April 2022, when it was made public, blaming the “time lag between October and February” on internal FDA issues.

Abbott’s Stoffel stated that there is a “ongoing investigation” into the October allegations, which “expand upon the federal OSHA allegations” from February 2021.

During their testimony in late May of this year, neither the FDA nor Abbott mentioned being alerted to an OSHA complaint raising product safety concerns in February 2021.

This was not the first time that concerns about quality control at the plant had been raised. According to an inspection report, the FDA discovered sanitation issues in Sturgis in September 2021, stating 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.” According to an inspection report, by February 1, the FDA had collected samples at the plant confirming the presence of cronobacter. Abbott maintains that there is no conclusive evidence that its products contributed to the illnesses or deaths of infants.

Following contamination concerns and a large recall of several of its brands, Abbott, the country’s largest manufacturer of infant formula, closed its Michigan plant in February 2022, exacerbating a nationwide shortage of infant formula. After meeting the initial requirements of an agreement with the FDA on how to reopen safely, it officially reopened its doors and resumed production in early June.