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.
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