FDA 483 - BlendHouse LLC - January 19, 2024

During an inspection from December 11, 2023, to January 19, 2024, the FDA issued a Form 483 to BlendHouse LLC, an infant formula manufacturer located in Reading, PA. The inspection revealed six significant observations indicating non-compliance with established manufacturing practices. Key issues included a failure to adequately clean and sanitize product contact surfaces, evidenced by extensive mold growth in a clean water tank used for batching infant formula, and a history of mold findings in the batch room. The facility also demonstrated poor building maintenance, with numerous roof leaks throughout 2023, some impacting manufacturing areas during production. Additionally, pest control was inadequate, with active flies observed in high-hygiene areas. BlendHouse LLC failed to adhere to its own production controls, specifically regarding discarding product after interventions into contact surfaces, and lacked proper quality assurance oversight. Critical thermal processing equipment temperatures were not consistently monitored according to procedures, with discrepancies between recording and indicating devices overlooked and affected infant formula lots released. Finally, potential raw material contamination risks were identified in a high-hygiene area due to unmonitored air pressure from an adjacent warehouse and recurring mold in air samples. BlendHouse LLC is required to address these observations with detailed corrective actions.