FDA 483 - Genetech Inc - June 22, 2018

Genetech, Inc. in San Diego, CA, was cited for numerous deficiencies during an inspection of its umbilical cord blood operations. The firm failed to properly determine and document donor eligibility, use FDA-licensed communicable disease tests, and establish a functional quality control unit. Significant issues were also noted in aseptic processing, environmental monitoring, process validation, stability testing, and record-keeping, indicating a pervasive lack of control and documentation.