Original title: FDA notified Abbott that pathogenic bacteria were detected in some areas of the milk powder factory involved, and there were quality control defects

  Beijing News (Chief Reporter Guo Tie) Abbott's recall of Sturgis, Michigan, USA, has made new progress in the incident involving pathogenic bacteria-contaminated milk powder.

The U.S. Food and Drug Administration (FDA) released an investigation report on March 22, local time, showing that Cronobacter sakazakii was detected in the milk powder filling room and drying area of ​​the factory. control system.

On March 24, Abbott China sent a statement to the Beijing News reporter saying that Abbott does not currently sell any nutritional products produced in the Sturgis factory in the United States in the Chinese mainland market.

  The FDA investigation report showed that Cronobacter sakazakii was positive in some areas of Abbott's Sturgis plant in the United States.

  On February 17, Abbott began a voluntary recall of Similac, Alimentum, and EleCare infant formula produced at the Sturgis facility due to the discovery of Cronobacter sakazakii in non-product contact areas of the facility.

The recall information includes products with the first two digits of the product code number 22 to 37, and the code on the container contains K8, SH or Z2, and the shelf life is April 1, 2022 and later.

  The latest FDA investigation report pointed out that environmental sampling of the Abbott Sturgis factory from January 2 to February 2, 2022 confirmed that the second and third areas of the high-level protection zone for infant milk powder in the factory existed Positive for Cronobacter sakazakii, involving milk powder filling area, drying area, etc.

  The FDA believes that there are three main problems in Abbott and Sturgis factories, including failure to establish a control system covering all processing of infant milk powder; failure to ensure that all surfaces that come into contact with infant milk powder are maintained to prevent milk powder from being polluted by the environment ; Staff who have direct contact with milk powder, raw materials, packaging or equipment and utensils do not wear necessary protective clothing.

  According to the FDA's latest notification, of the four consumer complaints currently under investigation, two hospitalized cases have reported deaths, and the FDA believes that Cronobacter sakazakii infection may be the cause of the deaths.

At the same time, Abbott has also expanded the scope of the recall to include Similac PM 60/40 with batch numbers 27032K80 (cans)/27032K800 (boxes) in addition to the above three products.

  The General Administration of Customs of China announced on February 20 that the above-mentioned Abbott products have not been exported to China through general trade, and that the special medical product Similac HMFortifi "Xikang Baby Tian", a special medical product produced by the involved company, has been sold to China. According to export records, Abbott China has initiated a voluntary recall.

Those who purchase relevant batches of infant formula milk powder from the company through non-general trade channels (such as Haitao) shall immediately suspend their consumption; those who purchase the above-mentioned special medical products shall immediately suspend their consumption.

  On March 24, Abbott China sent a statement to a reporter from the Beijing News saying that Abbott does not currently sell any nutritional products produced in the Sturgis, Michigan plant in the Chinese mainland market, and that the products comply with relevant national food safety standards and regulations. .

“We take this investigation seriously and are working closely with the US FDA to take corrective action. We have implemented corrective improvement actions at the factory, leveraged new technology and enhanced process controls so that when we resume operations at the Sturgis factory, consumers will be more aware of the The quality of our products is assured.”

  Guo Tie, chief reporter of the Beijing News