Abbott, FDA were warned about formula plant a year before recall

Abbott and the Food and Drug Administration were alerted to a whistleblower complaint about Abbott's Sturgis infant formula plant as far back as February 2021, ABC News has confirmed.

This complaint, filed with the U.S. Labor Department's Occupational Safety and Health Administration, alleges quality control concerns at Abbott's formula plant in Sturgis, Michigan -- a year before the company's massive recall and shutdown in February 2022 following contamination concerns, which helped exacerbate a nationwide shortage in baby formula, according to sources familiar with the matter.

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

The complaint raises further questions about when both Abbott and federal health authorities first knew about quality and contamination concerns at the Sturgis plant, and why it took so long for action to be taken.

The OSHA complaint, first reported by WSJ, alleges problems at the Sturgis plant like faulty equipment in need of repair or upgrade and inadequate safety validation for released product.

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 sources familiar with the matter.

The allegations made in that October report include "ongoing problems" with the "integrity" of seals on powdered products, that the facility had 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 the cleaning of equipment to "proliferate."

Abbott spokesperson Scott Stoffel told ABC News an internal investigation stemming from 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."

Responding to ABC News' request for comment, an FDA spokesperson acknowledged the shifting timeline of events leading up FDA's warning and Abbott's ultimate recall but would not comment specifically on the OSHA complaint.

"We know there have been various questions about the timeline of events leading up to the FDA's warning and Abbott's recall of products manufactured at their Sturgis facility," FDA spokesperson, Michael Felberbaum, said, adding the FDA's "top priority right now is addressing the dire need for infant formula in the U.S. market, and our teams are working night and day to help make that happen."

Felberbaum noted the FDA "can and must do better or be faster, and we've initiated a detailed after-action review so that we can make improvements to our programs, processes, and decision-making."

ABC was first to report that the FDA is now under audit by HHS-OIG for how it responded leading up to Abbott's massive recall -- probing 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 U.S. Nutrition Chris Calamari has testified under oath that the company was not aware of the October whistleblower complaint until late April 2022, when it was made public, blaming the "time lag between October and February" on FDA's internal issues.

Stoffel, of Abbott, said there is an "open investigation" into those October allegations that "expand upon the federal OSHA allegations" from February 2021.

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

This was not the first time questions had been raised about quality control at the plant. The FDA found sanitation issues in Sturgis in September 2021, saying 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. And by Feb. 1, FDA had collected samples at the plant confirming the presence of cronobacter, according to an inspection report. Abbott maintains there is no conclusive evidence that its products contributed to infants' illness or death.

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

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 reopen safely.

"Abbott takes employee concerns very seriously and we foster a culture of compliance to produce the best and highest-quality products," Stoffel said. "We empower our employees to identify and report any issues that could compromise our product safety or quality, which comes before any other considerations."

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