All Grifols plasma centers are licensed and regulated by the FDA and other, international agencies. Each plasma donation center is inspected and certified by those agencies every two years in addition to being monitored by the International Quality Plasma Program (IQPP). State health officials also inspect plasma centers to verify compliance with certain laboratory testing requirements and procedures. Grifols also has a robust internal regulatory program that routinely inspects and verifies the company's quality assurance requirements.

Pathogen safety has always been a core value and objective for Grifols. We are vigilant in our research of new and existing pathogen variants and mutations, and we routinely test our manufacturing processes and methods for the safety of our products. We also collaborate with industry member companies, through the Plasma Protein Therapeutics Association's Pathogen Safety Steering Committee, and with leading health authorities around the world. Our active internal pathogen safety group conducts careful and continuous scrutiny of scientific publications and daily news addressing new and emerging pathogens.

Important Safety Information
Because Grifols products are made from human plasma, they may carry a risk of transmitting infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Individuals who test positive for these viruses are immediately referred to a physician or clinic for formal medical diagnosis testing and treatment. They are also permanently deferred and excluded from donating plasma and are added to the National Donor Deferral Registry.

All donors must be screened for HIV, hepatitis B and hepatitis C at each donation using nucleic amplified testing (NAT), a state-of-the-art testing method that tests for the DNA particles of the virus. In addition, each plasma donation is tested for antibodies that the body produces in response to a virus. These screening tests are performed at the Grifols laboratories and are not formal medical diagnosis tests.