US FDA probe of Abbott facility finds quality control issues
The inspection from 31st January to 18th March showed that Abbott did not have a control system covering all stages of processing to prevent microbe contamination of infant formula
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 US health regulator said recently.
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 US Food and Drug Administration (FDA).
The inspection from 31st January to 18th March 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.
Cronobacter sakazakii bacteria can cause serious invasive infections and premature infant death.
Edits by EP News Bureau
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