FDA Inspection Flags Quality Control Issues At Abbott's Michigan Facility

An inspection at the Abbott Laboratories ABT facility in Sturgis, Michigan, found harmful bacteria on surfaces in some powdered baby formula production areas.

• The bacteria, Cronobacter sakazakii, can cause severe foodborne illness, mainly in infants.
• Last month, Abbott recalled certain Alimentum, Similac, and EleCare baby formulas after complaints that the facility's products had caused bacterial infections.
• The inspection from January 31 to March 18 showed that Abbott did not have a control system covering all processing stages to prevent microbe contamination.
• The FDA said that personnel working with infant formula also did not wear necessary protective apparel.
• According to the FDA, the observations raised are not final, and the Company can take corrective measures to address the issues presented.
• Abbott said it is currently reviewing the U.S. FDA's 483 observations from the inspection. "We're taking this very seriously and are working closely with the FDA to implement corrective actions," Abbott said.
• In its statement, the Company noted that no Cronobacter sakazakii or Salmonella was found in any testing of products distributed to consumers. 
• Additionally, the genetic makeup of the Cronobacter sakazakii microbes found in non-product areas at the Sturgis facility did not match the Cronobacter sakazakii microbes from the reported cases.
• Price Action: ABT shares closed 0.26% lower at $121.56 during after-hours trading on Tuesday.
• Editors' Note: The story has been updated to include Abbott's statement on powder formula recall.