Infant Formula Concerns

E. sakazakii in foods has resulted in over 60 documented infant related infections in the past 48 years. Increased surveillance has revealed yet more cases of this sometimes fatal infection. FDA policies have effectively resulted in a defacto zero tolerance; for Enterobacter sakazakii in infant formula has resulted in millions of dollars of economic losses for these manufacturers. Multiple lots are destroyed or reprocessed when even 1 of these organisms is present in 1332 grams of product. The prevalence of this organism in non-sterile infant formula ingredients and factory environments along with the high prevalence in infant formula (14% in on older survey although the incidence appears to be a good deal lower in United States presently) of extremely low numbers (<<1/gram) of this coliform has resulted in great financial hardship to the industry and human suffering to the victims. The potential for increased costs of infant formula and infant formula ingredients could well result in more infant mortality as consumers dilute formula beyond recommendations and children (likely to be the case in third world countries) become malnourished. Kornacki Microbiology Solutions has experience with locating and recommending corrective actions associated with microbial control in the infant formula industry.

World-class quality control systems and interventions are required to save both children and the industry. We have experience with control and detection of this organism in infant formula and with establishment of quality systems.