FDA 483 - BlendHouse LLC - December 21, 2022

The U.S. Food and Drug Administration (FDA) issued a Form 483 to BlendHouse LLC following an inspection from December 21, 2022, to February 17, 2023. The primary observation cited the company"s failure to establish an adequate system of process controls designed to ensure that infant formula does not become adulterated due to microbial contamination, specifically Cronobacter sakazakii. This critical issue was highlighted by multiple incidents, including the notification from a parent company in October 2022 about Cronobacter sakazakii in finished infant formula product where BlendHouse"s base was a component. The inspection revealed deficiencies in BlendHouse LLC"s subsequent root cause investigations, often concluding laboratory error despite external validation, or attributing contamination to failures in following standard operating procedures during equipment interventions. Furthermore, the company had previously identified Cronobacter sakazakii in its infant formula base in August 2022 due to inadequate sanitation practices. Review of the firm"s environmental monitoring program also confirmed recurring Cronobacter spp. in the manufacturing environment between July and September 2022. The FDA noted that these environmental findings were not adequately addressed, with insufficient root cause analyses, ineffective cleaning frequencies, and incomplete evaluations of potential contamination sources. These observations collectively indicate a systemic breakdown in microbial control. BlendHouse LLC is required to implement comprehensive corrective actions to address these significant concerns and ensure the safety and quality of its infant formula base products.