Quality and Regulatory Systems

As worldwide cell culture media providers, FUJIFILM Irvine Scientific is regulated and adheres to both ISO and FDA regulations with dual manufacturing facilities in California, USA and Tokyo, Japan. Leveraging our extensive experience as producers of cell culture media for the industrial bioprocess, medical, and diagnostic markets, industrial scale manufacturing capacity, and our compliance with ISO and FDA regulations for medical devices, we can provide customers with unique capabilities and support.

Our quality system principles start with a clear understanding that a robust Raw Material Program provides a gateway of assurance for lot-to-lot consistency in finished goods. The critical parameters built into our program incorporate the idea that the management of the Raw Material Program and the supply chain is the foundation for high quality product.


ISO 13485:2016 Certification