Licenses, Registrations and Permits

FDA

FDA Establishment Registration & Listing for HCT/Ps 1000507143 (Augusta)
FDA Establishment Registration & Listing for HCT/Ps 3003420280 (Atlanta)
FDA Establishment Registration & Listing for HCT/Ps 3013695843 (XTS)
FDA Establishment Registration & Listing for HCT/P 3014254056 (Athens)
FDA Establishment Registration & Listing for HCT/P 3017451050 (Marietta)
FDA Establishment Registration & Listing for HCT/P 3019356415 (Charlotte)
FDA Establishment Registration & Listing for HCT/P 3030249523 (Lawrenceville)

California Tissue Bank License CTB 00080397

California Tissue Bank License CTB 00080397

Georgia

Georgia Clinical Laboratory License 121-011 (Augusta)
Georgia Clinical Laboratory License 060-113 (Atlanta)
Georgia Clinical Laboratory License 029-034 (Athens)
Georgia Clinical Laboratory License 033-132 (Marietta)

Illinois

Illinois Sperm/Tissue Bank Registration #1309
Illinois Tissue Bank Registration (Cord Blood) #0209

Maryland

Tissue Bank Permit TB704

New York

New York State License for Tissue Bank Operation 235 (Augusta)
New York State License for Tissue Bank Operation 826 (Atlanta)
New York State Provisional License for Tissue Bank Operation 2549 (Athens)
New York State Provisional License for Tissue Bank Operation 2768 (Marietta)
New York State Provisional License for Tissue Bank Operation 2917 (Charlotte)

Oregon

Oregon Tissue Bank Registry (Augusta)
Oregon Tissue Bank Registry (Atlanta)
Oregon Tissue Bank Registry (Athens) 
Oregon Tissue Bank Registry (Marietta) 
Oregon Tissue Bank Registry (Charlotte) 

Regulation

Effective May 25, 2005, the U.S. Food and Drug Administration (FDA) commenced its regulation of reproductive tissue banks (21 CFR Part 1271). The FDA’s regulatory focus includes standards for the screening and testing of donors and proper record keeping procedures. Since these regulations were made effective, all major sperm banks have been audited for compliance by the FDA through on-site inspections. FDA inspections are performed on a continual basis.

In addition to federal regulation, most major sperm banks are also licensed and inspected by several states, particularly New York, California and Maryland. Licensing by state agencies began as early as 1992. Notwithstanding the regulatory oversight of government agencies and professional associations, most sperm banks have exercised self-regulation consistent with the highest medical and ethical standards. In fact, most major sperm banks were performing more than all the tests required by the FDA several years prior to the FDA’s effective date, and with greater frequency than required by the FDA and other regulatory agencies.