FDA 483 - Origin Biologics LLC - February 10, 2023
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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.
ID · 58e87ad3-782c-462e-af41-0fa659417b96