FDA 483 - UCP Bioscience Inc - November 18, 2024

UCF Bioscience Inc, a specification developer in Milpitas, CA, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate design history file documentation for a urine cup, failure to appoint a management representative for the quality system, and the absence of written medical device reporting procedures. These issues indicate a lack of robust quality control and regulatory compliance.