FDA Registration Certificate (Bethlehem, PA lab)

A sample of content in this file:

FDA information collection OMB Control number: 0910-0543, expiration date: 08/31/2026 Page 1 of 2 FEI: 3003368882 Devices: ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS DESCRIBED IN 21 CFR 1271.10 Reason For Last Submission: Change in Information Last Annual Registration Year: 2024 Last Registration Receipt Date: 11/21/2023 Summary Report Print Date: 12/01/2023 Donor Type(s) Recover Screen Donor Testing Package Process Store Label Distribute Date of Discontinuance Date of Resumption Amniotic Membrane Blood Vessel Bone Cardiac Tissue - non-valved Cartilage Cornea Dura Mater Embryo Fascia Heart Valve HPC Apheresis HPC Cord Blood Ligament Nerve Tissue Oocyte Ovarian Tissue Pancreatic Islet Cells - autologous Parathyroid Pericardium Peripheral Blood Mononuclear Cells Peritoneal Membrane Sclera Semen Skin Tendon Testicular Tissue Tooth Pulp Umbilical Cord Tissue Satellite Recovery Establishment: Parent Manufacturing Establishment FEI No.: Note: FDA acceptance of an establishment registration and HCT/P listing does not constitute a determination that an establishment is in compliance with applicable rules and regulations or that the HCT/P is licensed or approved by FDA (21 CFR 1271.27(b)). Proprietary Name(s) Establishment Functions HCT/P(s) FEI: 3003368882 Legal Name: Lions World Vision Institute Testing For Micro-Organisms Only: No FOOD AND DRUG ADMINISTRATION Blood: Drugs: Other FDA Registrations: Legal Name and Location: 2591 Bagylos Circle Lions World Vision Institute Suite C-46 Bethlehem, Pennsylvania 18020 USA Phone: 610-625-3800 Ext.: Reporting Official: Katrina D Capuzzo, Senior Quality Assurance Manager 1200 6th Ave Ste 300 Seattle, Washington 98101 USA Phone: 206-838-4626 Ext. katrina.capuzzo@lwvi.org