Following the recall,FDA investigators reportedly found multiple deficiencies and problems at the Similac manufacturing facility, including leaks in the roof that allowed water to enter and sit stagnant on the floor and on production equipment. However, few details have been released by the Abbott or federal regulators.
In recent months, the Sturgis, Michigan facility has been slowly allowed to come back online, manufacturing limited amounts of EleCare and other specialty formulas. However, the formula plant was shut down due to flooding in June 2022, and the company just recently announced that full production of Similac will resume again in 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 was announced.
According to the report, the inspection was a year overdue because of the pandemic, and FDA inspectors noted that cronobacter was detected at the facility five times in the past two years, and twice found its way into cans that were prepared for distribution before being caught. However, despite holding back those cans where cronobacter was detected, Abbott failed to recall the entire batches or notify the FDA.
Inspectors observed how the problem might have spread when they saw a worker reach into a bag of ingredients without cleaning his gloves or hands. In addition, they found pitted and cracked drying equipment, which could be bacterial breeding grounds, as well as pools of standing water.
During the September inspection, the FDA and Abbott received a report of a child falling ill with cronobacter in Minnesota after eating Similac Sensitive made at the Sturgis facility. While both the agency and the company knew about the incident, neither informed the inspectors.
Instead, the FDA just trusted Abbott would fix the problem. It was not until a follow-up inspection in January that the FDA decided to take action, when they found five different strains of cronobacter in the facility.
Similac & Enfamil Baby Formula Health Risks
In addition to concerns about contaminated baby formula produced at the Michigan facility, Abbott is also facing hundreds of Similac lawsuits brought by families of premature babies who developed necrotizing enterocolitis (NEC) after being fed the cow’s milk products while still in the NICU.
