FDA 483 - SAFC Carlsbad Inc. - December 16, 2021

SAFC Carlsbad Inc. in Carlsbad, CA, was inspected and cited for multiple deficiencies related to manufacturing controls and quality systems. Key issues include inadequate environmental controls, improper biohazardous waste management leading to cross-contamination risks, insufficient raw material identity testing, and deficiencies in aseptic process validation. These findings indicate a lack of robust controls to ensure product quality and safety.