ByHeart Inc dba Blendhouse Allerton – FDA 483, Feb 11, 2025

During an inspection conducted from February 11-20, 2025, the Food and Drug Administration (FDA) issued a Form 483 to Blendhouse Allerton, LLC, identifying significant objectionable conditions at their manufacturing facility. The observations primarily centered on three critical areas, indicating potential violations of the Food, Drug, and Cosmetic Act concerning infant formula production.

Firstly, the company approved and released ingredients for infant formula manufacturing despite clear evidence of rodent contamination, including torn packaging and excreta, without adequately investigating the root cause of these issues. Furthermore, inspectors noted inadequate employee hygiene during pre-weighing operations, where employees" smock arms, which touched external packaging, also contacted internal product without proper glove changes or hand sanitization.

Secondly, the facility demonstrated ineffective pest exclusion. Evidence included recurrent sightings of live and dead mice within the plant, numerous rodent captures on the exterior premises, and the presence of unaddressed potential harborage sites in the warehouse, indicating a systemic failure in pest control.

Finally, sanitation and building maintenance were found to be deficient. Observers noted rusty and peeling surfaces on the dryer level floor, which had confirmed findings of Cronobacter Sakazakii and lacked adequate environmental monitoring. This issue, contributing to potential microbial harborage, was identified as a repeat observation from a prior inspection.

Blendhouse Allerton, LLC is required to address these findings by developing and implementing comprehensive corrective actions to ensure compliance with regulatory standards and prevent product adulteration.