We have set the highest Quality Standards, which are at the heart of cGMP Facility operations. The Facility operates under the established, well proven Quality System, evaluated at regular intervals through internal and external audits performed by an independent Quality Unit, and FDA and leading national and international organizations, respectively.

• FDA Registration

In 2016 the FDA has published the final rule for manufacturers of Human Cells, Tissue and Cellular and Tissue-Based Products (HCT/Ps), regulated as drugs, devices, and /or biological products products under section 351 of the PHS Act or under Food, Drug, and Cosmetic Act. Such facilities must register and list their products with the FDA according to the Drug Establishment Registration and Listing or Device Registration and Listing.

CGMP Facility has been registered with the FDA since 2003. To download our current FDA registration certificate, click here.

• Additional Accreditations

  The accreditation process is based on consistent long-term performance guided by the established Quality System. cGMP Facility was the first somatic cell facility accredited by FACT (Foundation for Accreditation of Cellular Therapy) back in 2006, and AABB in 2007.