Registration, Licenses & Certificates

INCELL currently has various types of registrations, licenses and certifications 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;
    • Current Certification
      https://www.fda.gov/cber/tissue/tisreg.htm
    • Establishment FEI#3004107906
  • State Tissue Bank registrations and licenses:
    • Active Annual Registrations
      *Delaware   *Illinois
      *Oregon       *California
    • Licenses
      *Pending Applications: New York
  • American Association of Tissue Banks (AATB)
    • National Facility Certification in Review
    • Certified Tissue Banking Specialists (CTBS)
    • 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
• State Licensing:
  • Texas Department of State Health Services Texas “Prescription Drug Manufacturer” License #1001922; Exp. 27 April 2021
• Corporate Registrations, Licenses and Certifications
  • General
    • DUNS Number: 965420953
    • NAICS Codes: 325414, 325413, 325411, 541380, 541690, 541710, 541711, 541990
    • Credit Card Security through Trustwave Certificate of Compliance
    • System Award Management (SAM) Registration: US Federal Contractor Database
    • www.grants.gov registration for US government granting agencies
  • Small Business Certifications
    • South Central Texas Regional Certification Agency (SCTRCA) as Small Business Enterprise/Women-Owned Business Enterprise (SBE/WBE) #218055138; Exp. 30 June 2024
    • State of Texas HUB Vendor Certification #68402; Exp. 30 June 2024
  • Annual Vendor Certifications of Facilities and Equipment for GMP Manufacturing
  • Applications Planned or Pending: ISO, CLIA, FACT, AABB