Regulatory Information

Our Commitment is Patient Safety, Product Quality, and Innovative Research & Development

Complying with Federal, State and local regulations is essential to ensure patient safety and promote public trust. Regenerative Processing Plant (RPP) is registered with the U. S. Food and Drug Administration (FDA).
RPP has filed applications with all governing entities that may require licensure, registration and/or certification and our associate processing facility is ISO 13485: 2003 certified.

Regenerative Processing Plant is committed to providing the medical community with innovative regenerative products manufactured under current Good Manufacturing Practices (cGMP) regulated by the FDA. All of RPP’s products are manufactured under the guidelines of 21 CFR; Part 1271; section 361 of the Public Health Act.

Donor Quality and Screening for Patient and Product Safety:

Regenerative Processing Plant utilizes a laboratory registered with the FDA to perform Communicable disease donor testing and is certified to perform such testing on human specimens in accordance with Clinical Laboratory Improvement Amendments (CLIA) and 42 CFR Part 493, or that has equivalent requirements as determined by the Centers for Medicare and Medicaid Services. Communicable disease testing has been performed, names and addresses of testing laboratories, interpretation of all required infectious disease tests, and a listing of the documents reviewed as part of the relevant medical records are kept on file at RPP and are made available upon request.

Blood samples were given by the donor prior to or at the time of collection and were tested by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) and were found negative using FDA licensed tests for, at minimum:

    • HBsAg: Hepatitis B Surface Antigen
    • HBcAb: Hepatitis B Core Antibody
    • HCVAb: Hepatitis C Antibody
    • HIV 1/2/Ab: Human Immunodeficiency Virus Types 1/2 and O Antibody
    • HCV NAT: Hepatitis C Virus
    • HIV NAT: Human Immunodeficiency Virus
    • HBV NAT: Hepatitis B Virus
    • RPR/STS or Equivalent: Syphilis