Registrations Licenses & Certifications

INCELL currently has various types of registrations, licenses and certifications related to the storage, processing, manufacturing, testing and distribution of regenerative medicine cell and tissue products and is seeking others.

• Human Cell and Tissue Products (HCT/Ps): Manufacturing, Banking, Distribution
  • USA registration with Center for Biologics Evaluation and Research (CBER) FDA;
    https://www.fda.gov/cber/tissue/tisreg.htm Establishment FEI#3004107906
    

      INCELL_HCTP_Registration_FDA3356_FEI3004107906A2015A.pdf (11.7 KiB, 2,419 hits)

  • State Tissue Bank registrations and licenses:
    • Active Annual Registrations
      *Delaware
      *Illinois
      *Oregon
    • Licenses
      *Florida License #245
      *Pending Applications: California; New York
  • American Association of Tissue Banks (AATB)
    • National Facility Certification in Review
    • Certified Tissue Banking Specialists (CTBS); 2015: Certified Senior Managers:
      • Lynn Miller, QA
      • Mary Pat Moyer, PhD

• Medical device manufacturer registered with Center for Devices and Radiological Health (CDRH) FDA;
  https://www.fda.gov/medicaldevices ; Focus on sterile liquid fill products
  • Establishment Registration Number: 3004107906
  • Owner Operator Number: 9057577

Other Registrations Licenses & Certifications can be found here.