Abbott infant formula plant linked to Similac food poisonings had numerous structural and procedural issues: report

Following the recall, FDA investigators reportedly discovered multiple deficiencies and issues at Similac’s manufacturing facility, including roof leaks that allowed water to enter and collect on the floor and on the roof. production equipment. However, few details have been released by Abbott or federal regulators.

In recent months, the Sturgis, Michigan plant has been slowly allowed to come back online, manufacturing limited quantities of EleCare and other specialty formulas. However, the formula plant was closed due to flooding in June 2022, and the company has just announced that full production of Similac will resume within the next six weeks.

FDA found problems months before recall

The Bloomberg report dives deep into what FDA inspectors found during their inspections of the Abbott facility in September 2021; months before the recall announcement.

According to the report, the inspection was overdue by a year due to the pandemic, and FDA inspectors noted that cronobacter has been detected at the facility five times in the past two years and has found twice in boxes that were prepared for distribution before being captured. . However, although it withheld the boxes where cronobacter was detected, Abbott did not recall the entire lots or notify the FDA.

Inspectors observed how the problem could have spread when they saw a worker rummaging through a bag of ingredients without washing gloves or hands. Additionally, they found sunken and cracked drying equipment, which could be breeding grounds for bacteria, as well as pools of standing water.

During the September inspection, the FDA and Abbott received a report of a child who fell ill with cronobacter in Minnesota after eating Similac Sensitive manufactured at the Sturgis facility. Although both the agency and the company were aware of the incident, neither informed the inspectors.

Instead, the FDA simply trusted Abbott to fix the problem. It wasn’t until a follow-up inspection in January that the FDA decided to act, when it found five different strains of cronobacter at the facility.

Health Risks of Similac and Enfamil Infant Formula

In addition to concerns over contaminated infant formula produced at the Michigan plant, Abbott is also facing hundreds of Similar lawsuits contributed by families of premature babies who developed necrotizing enterocolitis (NEC) after being fed cow’s milk products while still in the NICU.

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