FDA 483 - Abbott Laboratories - October 22, 2010

Abbott Nutrition in Sturgis, MI, was cited for significant issues related to contamination control and pest exclusion during an FDA inspection. Observations included defective equipment design allowing beetles into the product stream, a long-standing failure to control warehouse and flour beetle infestations, and the presence of metal fragments in raw materials used for infant formula. These findings indicate serious deficiencies in maintaining sanitary conditions and product integrity.