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Compliance

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.

Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Title 21 – Food and Drugs Part 1271.10 – Human Cells, Tissues, and Cellular and Tissue- Based Products - HCT/P’s

AATB Guidance Documents

Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use

Title 21 – Current Good Tissue Practice Sec. 1271.150

Current Good Manufacturing Practice Regulations cGMP

Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271

Tissue and Tissue Products

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The RICHGEN® product line is represented exclusively by RichSource, a Florida Corporation. Copyright © 2018-2020. | Privacy Policy | Terms & Conditions | Disclaimer

RichSource is rapidly educating practitioners who are ready to replace risky, time consuming and outdated techniques. In addition, the RichSource superior products are umbilical cord blood free. Our standards are very advanced in producing the most reliable injectables in full compliance.

The Facts About Bone Marrow Aspirate

See Regenexx: United States of America v. Regenerative Sciences, LLC No. 12-5254 Appellate Ruling dated February 4, 2014.

Caution – be careful what you use:

Predictive Biotech single material Wharton jelly independent lab test by Dr. Spencer shows only 2.4% viability. See Predictive screen shot.
Also, the test showed only 2/3 the quantity of cells versus what is promoted. Click here to see the video.

Bone marrow cell extraction has resulted in serious infections and the cell counts reduce dramatically with age. See the chart in our brochure. Adipose cell extraction has resulted in adverse reactions causing blindness and stroke. Both procedures cause patient discomfort.

Is bone marrow surgery risky? NJ Principal dies donating bone marrow. Do bone marrow extraction practices follow processing and labeling FDCA and PHSA regulations? See United States of America v. Regenerative Sciences, LLC No. 12-5254 Appellate Ruling dated February 4, 2014.

Utah Cord Bank lab test tissue clump debris in photo. Test shows no viability.

Mimedx Injectables Do Not Meet FDA Standards – WSJ article.

Umbilical cord blood myths and side effects.

Umbilical cord blood product by Liveyon recalled. Product does not have MSCs? Counts are heavily marketed although not allowed by the FDA.

Please see RICHGEN report on Maximum Signaling for Maximum Regeneration about potency is more important than counts.

Efficacy of PRP Study: No improvement

FDA rules exosomes products being sold are not licensed and approved.
FDA Public Safety Notice Bans Exosome Products.

Caution – be careful what you use:

Predictive Biotech Wharton jelly product viability independent testing is only 2.4% versus what is claimed per Dr. Eliott Spencer, PhD.

Bone marrow cell extraction has resulted in serious infections and the cell counts reduce dramatically with age. See the chart in our brochure. Adipose cell extraction has resulted in adverse reactions causing blindness and stroke. Both procedures cause patient discomfort.

Is bone marrow surgery risky? NJ Principal dies donating bone marrow. Do bone marrow extraction practices follow processing and labeling FDCA and PHSA regulations? See United States of America v. Regenerative Sciences, LLC No. 12-5254 Appellate Ruling dated February 4, 2014.

Utah Cord Bank lab test tissue clump debris in photo.

Mimedx Injectables Do Not Meet FDA Standards – WSJ article.

Efficacy of PRP Study: No improvement

Umbilical Cord “Stem Cell” Infusion Side Effects: What you need to know…

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