Following sporadic cases of infection with Cronobacter sakazakii (an enterobacter) the FDA has initiated a recall of batches of Abbott Infant Formula marketed under the Similac™ brand manufactured at the Sturgis, MI. plant.  According to FDA records, since October 2008, three of 27 inspections demonstrated deficiencies in good manufacturing practices with problems revealed in 2010, 2019, and 2021.

Abbott has acknowledged evidence of Cronobacter sakazakii in their plant but has denied that QC identified this organism in product.  Notwithstanding this contention, there are records showing destruction of product presuming contamination with either Cronobacter, Salmonella or some other pathogen.

Bill Maler, a prominent plaintiff’s attorney specializing in foodborne infection, has questioned the diligence of the FDA in following up on documented deficiencies in the Sturgis plant operated by Abbott.

This case indicates that FDA is failing to protect public health given the obligation of the Agency to prevent release of contaminated or adulterated foods including infant formula. Frequent outbreaks of foodborne disease in the U.S. justify the establishment of a dedicated food safety agency as in other nations. This will allow the FDA to devote their resources and personnel to the primary function of ensuring the safety of drugs and medical devices.