FDA Guidance for Industry
RichSource represents the RICHGEN product line biologics that are manufactured in full compliance at a FDA registered tissue processing lab in Florida. The biologics are regulated as human cellular or tissue-based product (HCT/P) under 21 CFR Part 1271.10 and Section 361 of the Public Health Service Act, FDA and ISO 13485 guidelines. FDA, AATB, cGMP and cGTP compliant. The Amniosomes™ exosomes FDA IND application submission was made April 14, 2020. The flowable allograft FDA IND application submission will be made shortly.