Center For Cell & Gene Therapy – FDA EIR, Dec 29, 2016

An FDA inspection of the Center For Cell & Gene Therapy in Houston, TX, was conducted from December 27-29, 2016. This initial comprehensive inspection, performed under Compliance Program 7341.002 for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), specifically focused on their umbilical cord blood storage and distribution operations. The inspection covered Good Manufacturing Practices (GMPs) and Good Tissue Practices (GTPs), including equipment maintenance, aseptic technique, storage, labeling, thawing procedures, training, and deviation handling.

Notably, the inspection concluded with no deficiencies identified, and no FDA-483 was issued. However, management was advised to update the firm's FDA registration to accurately reflect their actual activities. The company currently receives, stores, thaws, tests for sterility, and distributes umbilical cord blood, but is registered for additional steps like recovery, screening, packaging, and processing that they do not perform. The firm promised to make these corrections. The inspection also involved reviewing patient records, including instances where cord blood from donors with incomplete testing was used in medical emergencies with parental consent, and a variance report concerning cell viability.