FDA 483 - Origin Biologics LLC - February 10, 2023

This FDA Form 483 report for Origin Biologics LLC identifies critical deficiencies across multiple areas of their HCT/P manufacturing operations. Significant issues include inadequate environmental controls, failed cleanroom qualifications, uninvestigated microbial contamination, and a lack of proper deviation investigations. The firm also failed to validate key processes and maintain equipment calibration, indicating systemic problems that could compromise product quality and safety.