Quality/Regulatory

Lee Biosolutions is committed to delivering high quality, compliant products to its customers. This is reflected throughout the organization, from risk-based vendor selection, to Quality Assurance putting it's stamp of approval on every product shipped from our facility. To us, it's more than a hot-button word. It's what guides our actions and allows us to compete in the marketplace.

Some of our operations are subject to regulation by various U.S. state, federal and international agencies, including the DNR, FDA, MSD, USDA and other comparable U.S., state, local and foreign governmental agencies.

These regulations govern a wide variety of product activities, from research and development to manufacturing, handling, sales, distribution, importing and exporting of products. We have a very active compliance program in order to meet current and future requirements. Copies of permits and licenses are available upon request.

Certifications

• ISO 13485 (Perry Johnson Registrars, Inc.)
• FDA CBER Blood & IVD Registration No: 3004343130
• APHIS Reference/Technical Blood Permit No: MO-INT-0002 (Compliance with Regulation (EC) 1069/2009 and Regulation (EU) 142/2011)