The FDA produced this 2022 483 inspection report – presumably the location of the facility purchased by ByHeart.
Inspection Report 2023 (483 not provided and Exhibits not provided) – “You did not maintain a building used in the manufacture, processing, packing or holding of infant formula in a plain and sanitary condition.” “In informed all parties that continuous improvement and routine maintenance of the aging facility would be vital to prevent contamination of the powered infant formula supply.”
Inspection Report 2024 (483 not issued and Exhibits not provided) – “There were numerous complaints regarding product quality and some specifically mentioning issues like spitting-up and diarrhea.” “Although I did not uncover any significant negative findings during the inspection, the next investigator may discover issues or conditions that were not addressed during this inspection.”
Inspection Report 2025 (Exhibits not provided) – “At the close-out of the inspection, a Form FDA 483, Inspectional Observations, was issued for 3 items, along with a ‘Additional Observations,’ and 7 ‘General Discussion with Management. The three 483 items included, receiving, and releasing ___________ ingredient used in infant formula has powder that was not held under conditions to prevent adulteration, not taking actions to eliminate all potential harborage areas when issues with rodent arose during the year 2024-2025; not monitoring the floor conditions adequately at the dryer ____ (level __ and level __) when there were findings of confirmed Cronobacter Sakazakii.” ” The two additional observations consists of the firm not having clear barriers separating hygiene zones; and not monitoring bathhouse differential pressures.”
483 2025 – “Observation 1: You approved and released for use an ingredient that was not manufactured, packages, labeled, or held under conditions to prevent adulteration.” “Observation 2: You did not exclude pests from your food plant to protect against contamination of food.” “Observation 3: You did not maintain a building used in the manufacture, processing, packing or holding infant formula in a clean and sanitary condition.”
