The U.S. FDA has issued a series of warning letters to three manufacturers of infant formulas regarding the results of inspections of their facilities. According to the agency Press Release, ByHeart Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin LLC will have 15 days to send an improvement plan to the FDA in order to maintain compliance.
According to the FDA, over the last several months a series of agency inspections have issued observations and oversight notes to each of the firms and initiated recalls in December 2022, February 2023, and March 2023. These inspections and recalls were intended to prevent the distribution of formula contaminated with Cronobacter sakazakii.
According to the U.S. Centers For Disease Control and Prevention (CDC), Cronobacter infections are typically rare but can be deadly for infants. The most vulnerable infants are those less than 2 months old, those born prematurely, and those with weakened immune systems as the result of illness or chemotherapy.
Symptoms of Cronobacter infection include:
- Poor feeding
- Excessive crying
- Low energy
Additionally, in particularly vulnerable infants, the Cronobacter infection can get into the blood and lining surrounding the brain or spine and lead to meningitis. Meningitis can lead to severe and extensive brain injury and has a death rate of 20% in the United States.
Despite the potential risk, the FDA does not currently advise any parents or caregivers to discard or avoid infant formula from ByHeart, Mead Johnson Nutrition, or Perrigo Wisconsin. The agency stated that it “is not aware of any distributed product where contamination was confirmed” and believes that the recalls effectively removed the potentially contaminated batches of infant formula from the stream of commerce. Additionally, the FDA does not believe that these warning letters will have an impact on the availability of infant formula in the United States.
The manufacturers will now be required to enact a number of changes, including:
- Thoroughly conducting root cause investigations
- Performing cleaning and sanitation activities in their facilities
- Evaluating the practices and schedules of their sanitation practices
Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition, noted that “Infant formula manufacturers are responsible for ensuring they make safe products, . . . the agency has remained in ongoing discussions with the infant formula industry to address the agency’s concerns.”
If you have been harmed by a contaminated food product, you may be eligible for financial compensation. Contact MedTruth today for a free case evaluation and begin your journey to justice.