TOTAL QUALITY MANAGEMENT

As part of the California Cryobank family, Kitazato USA has the benefit of being part of a robust, industry-leading, total-quality management system. We ensure compliance with the regulations established by the FDA as a Medical Device distributor. Our Quality Manual is designed to establish quality assurance and quality control expectations, provide continuous process improvement descriptions, and demonstrate compliance with applicable regulations.

Quality Policy
Through our mission and values, California Cryobank and each of its employees is committed to providing reproductive and stem cell products and services of the highest quality through:

  • Establishing and adhering to a total Quality Management System
  • Dedicating resources to the continuous improvement of our systems
  • Complying with global regulatory requirements and accrediting standards
  • Listening to customer needs and translating them into our products and services

Our total quality management system ensures systems are established for Deviation and CAPA Management, Change Control, Complaints, Document Control, Internal Audits, Vendor Management, Equipment and Material Management, Validation and Qualification, Inventory Rotation, Training, and Risk Management.

QUALITY CERTIFICATIONS & CERTIFICATE OF ANALYSIS (COA)

Kitazato USA is committed to ensuring the quality and safety of products and services for our customers. Kitazato’s manufacturing facility reflects this committment through a quality control program of the manufacturing processes, equipment, and methods. Each lot is issued with its own Certificate of Analysis confirming that the product meets our high standards of quality.

PACKAGING

Testing is performed on all primary packaging to guarantee they are sterile and non-toxic. Our products are packed, as appropriate, in validated containers to ensure optimal temperature conditions.

MANUFACTURING FACILITY

All Kitazato USA products are from Kitazato in Fuji City (Shizuoka), Japan, where quality and compliance is integrated throughout all processes. The Kitazato manufacturing facility was established in 2005 and has invested heavily in the finest technology to provide the best quality control in laboratories and processes, as well as controlled storage. Kitazato’s finished product distribution system generates the highest quality products.

Quality is at the core of Kitazato’s principles. From the use of advanced technology and controlled raw materials, to the expertise of a highly-trained team, Kitazato’s products are single-use, disposable, and sterilized. Each component comes from the highest quality raw materials and has passed through rigorous quality controls for acceptance. All products are properly stored and distributed within an efficient cold-chain through thermal and refrigerated packaging methods when necessary.