Quality 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.

Our Mission

FUJIFILM Irvine Scientific is setting
the standard for excellence through:

Quality Products for the Cell Culture,
Diagnostics, and Biopharmaceutical markets

Quality Service with respect, courtesy and
loyalty to our customers

Quality People dedicated to complete
customer satisfaction

Customer satisfaction is not our goal…
It is our policy!

FUJIFILM Irvine Scientific Quality Policy

FUJIFILM Irvine Scientific strives to be the top performer for our clients across all business
units and build relationships of trust with our customers.

We establish, review and communicate our Quality Objectives
throughout our organization, to assure understanding, continuing suitability and
to maintain the effectiveness of our Quality Management Systems.

Our quality management system is committed to comply with the requirements
applicable to the markets we serve.

Quality Audits

Please contact us at ISAudits@irvinesci.com for On-site Audit inquiries, audit correspondence & submitting audit report & responses:


ISO 13485:2016 Certification