Supplier Qualification: What You and Your Clinic Need to Know Before You Order Donor Semen
Clinics are responsible for making sure that all outside establishments used to perform any steps in the donor screening and/or testing process are registered with the FDA and compliant with all applicable requirements, as per the FDA ruling 21 CFR Part 1271.
We have drafted a contract establishment agreement for your clinic to use. Your clinic will fill the name and address of their establishment and then fax it to our Compliance Officer at 703-991-2671. She will then sign the document and return to your facility.
CLI is proudly registered with FDA, licensed with CLIA, NY State, CA State, MD State and accredited with the American Association of Tissue Bank (AATB). See our current licensure here.
Visit our website for additional information on compliance.
