FDA Guidance for Industry
RichSource represents the new RICHGEN product line manufactured at a FDA certified and registered tissue processing lab in Florida. The lab is also AATB certified. 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.