Nara’s German manufacturer fails FDA inspection

Milchwerke “Mittelelbe” GmbH, the German manufacturer of Nara Organic’s Whole Milk Infant Formula, has been added to the FDA’s Import Alert 40-05 list after an inspection of the production facility found “serious deviations of the Infant Formula Requirements per 21 CFR Part 106.”

Import Alert 40-05 provides specifically for “Detention Without Physical Examination Of Adulterated And Misbranded Infant Formula.”

The entry for Milchwerke “Mittelelbe” GmbH, dated 06/26/2026, states that “…the firm’s powdered infant formula products processed in the facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, in that they were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health.”

The Import Alert cited the lack of a flow diversion valve on the pasteurization system, failure to take corrective action following the detection of Cronobacter sakazakii in a “high-hygiene” zone of the processing facility, inadequate environmental monitoring for Cronobacter sakazakii, failure to maintain the plant in a clean and sanitary condition, and lapses in good personal hygiene practices.

Perhaps the most troubling of these observations is the lack of a flow diversion valve. This valve is designed to monitor the temperature of the milk at the outflow from the holding tube immediately after pasteurization and to divert the milk back into the tank if the temperature at the outflow point is below the required level. The absence of an proper flow diversion valve could result in underpasteurized milk being introduced into the spray-drying process and, thus, into the infant formula powder.

Coming a close second is the inadequate follow-up on detection of Cronobacter sakazakii in the production environment. After finding the pathogen and conducting a “root cause” analysis to determine the source of the contamination, the company failed to take “appropriate and timely” corrective measures.

The abbreviated inspection report summary included in the Import Alert notification also mentioned “cracked and pitted concrete floors, broken and missing tiles, and damaged grout” in areas where the infant formula is processed.

To be clear, the Nara Organics powdered infant formula batches implicated in the infant botulism outbreak currently under investigtion were not manufactured by Milchwerke “Mittelelbe” GmbH. They were produced, presumably in the USA, using organic whole milk powder produced and processed by the same US supplier that produced the whole milk powder used in ByHeart’s organic infant formula powder.

Nevertheless, the picture painted by the FDA’s Import Alert is very different from Nara’s rosy description of a “state-of-the-art” facility.

According to the FDA’s updated Outbreak Investigation report, the agency is in the process of reviewing corrective responses submitted by Milchwerke “Mittelelbe” GmbH, and also has been in contact with relevant European authorities.