- The Food and Drug Administration sent warning letters for operational violations to baby formula manufacturers Perrigo Wisconsin, ByHeart and Mead Johnson Nutrition on Aug. 30, part of the agency’s ongoing oversight of the sector.
- The warning letters follow voluntary recalls last year by each formula maker due to products potentially contaminated with Cronobacter sakazakii, a bacteria that can cause a deadly infection in infants.
- In all three letters, the agency highlighted the companies’ failure to establish “a system of process controls” to ensure formula does not become contaminated by microorganisms in the product or facility. The companies have 15 days to respond to the FDA’s warning.
The FDA has been vocal about its actions to more aggressively oversee baby formula manufacturing, after a nationwide shortage roiled the sector last year when a Cronobacter contamination caused a shutdown at an Abbott Nutrition plant.
In May, the agency released an outline of its strategy to enhance production safety in the sector, including collaborating with stakeholders to better understand best manufacturing practices and considering the establishment of dedicated investigators to conduct infant formula inspections.
The agency also plans to review and update guidance on powdered baby formula production and evaluate current testing requirements for improvement.
The FDA’s recent warning letters are part of its normal and ongoing regulatory process in the sector, according to an agency spokesperson.
“The FDA is issuing these letters now as part of its normal regulatory process and to reinforce to these firms the importance of instituting and maintaining appropriate corrective actions,” a spokesperson said in an email to Manufacturing Dive.
The agency noted the letters are not part of any recall and does not advise parents to discard any formula product.
Each of the formula makers was inspected earlier this year, from which they received violations pertaining to their operations. And while Perrigo, ByHeart and Mead Johnson sent responses to the FDA outlining corrective actions to address their violations in the following months, those actions did not fully address the agency’s concerns.
“The firms now have 15 working days to notify the FDA of the specific steps they have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur,” according to the spokesperson.
In addition to the FDA’s callout regarding the companies’ lack of process controls, Mead Johnson was cited for not conducting a fully thorough root cause analysis of how the contamination occurred, as well as for not ensuring production equipment was appropriately designed, cleaned and operational.
Mead Johnson did not respond to a request for comment.
ByHeart and Perrigo were similarly critiqued regarding their root cause analysis of how the contamination occurred, including for their environmental monitoring programs, meant to prevent the existence of pathogens in dry production areas.
ByHeart did not respond to a request for comment.
“The letter Perrigo received pertained only to its infant formula manufacturing facility located in Wisconsin, which Perrigo acquired from Nestle on November 1, 2022,” a Perrigo spokesperson said in an email. “This letter relates to a routine inspection by the FDA which began on March 6, 2023 and references FDA’s March 8, 2023 communication to the infant formula industry outlining its evolving regulatory expectations. We are in the process of carefully reviewing FDA’s letter and plan to work closely with the agency.”
The FDA has already scheduled the three firms for re-inspection but is not publicizing the dates of the visits, according to the spokesperson. “FDA will be reinspecting the firms to verify proper implementation of appropriate corrective actions.”