FDA Probe of Abbott Facility Finds Quality Control Issues

By Reuters Staff

March 24, 2022

(Reuters) - An inspection at the Abbott Laboratories facility in Sturgis, Michigan found a harmful bacteria called Cronobacter sakazakii on the surface of some areas producing its powdered baby formula, the U.S. health regulator said on Tuesday.

Complaints that the facility's products had caused bacterial infections forced Abbott to recall certain Alimentum, Similac and EleCare baby formulas last month, prompting a probe from the U.S. Food and Drug Administration (FDA).

The inspection from Jan. 31 to March 18 showed that Abbott did not have a control system covering all stages of processing to prevent microbe contamination of infant formula.

Personnel working with infant formula also did not wear necessary protective apparel, the FDA said.

"We're taking this very seriously and are working closely with the FDA to implement corrective actions," Abbott said in a statement.

No Cronobacter sakazakii was found during the company's testing of products that were distributed to consumers, Abbott added.

The company also said that the genetic makeup of the Cronobacter sakazakii found at the Michigan plant did not match that of the reported cases.

Gram-negative Enterobacteriaceae, Cronobacter sakazakii can cause serious invasive infections and premature infant death.