FDA WARNING_LETTER - pa green wellness llc - August 17, 2020

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore pa green wellness llc

Record Details

The FDA and FTC issued a Warning Letter to PA Green Wellness, LLC (dba Predictive Laboratories, Inc.) regarding their umbilical cord-derived product, CoreCyte™. The agencies reviewed the company's websites, www.pagreenwellness.com and www.facebook.com/PAGreenWellness, in August 2020.

CoreCyte™ is promoted for sale to patients in the U.S. with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. The FDA determined CoreCyte™ is a human cell, tissue, or cellular or tissue-based product (HCT/P) but does not meet the criteria for regulation solely under section 361 of the PHS Act (21 C.F.R. Part 1271). Specifically, it fails the homologous use criterion (21 C.F.R. § 1271.10(a)(2)) as its intended use for COVID-19 is not homologous to the umbilical cord's original function. Additionally, it appears to fail the minimal manipulation criterion (21 C.F.R. § 1271.10(a)(1)).

Therefore, CoreCyte™ is regulated as an unapproved new drug under section 505 of the FD&C Act (21 U.S.C. § 355) and a misbranded drug under

Company: pa green wellness llc
Inspection Date: August 17, 2020
Product Type: Biologics
Office: Center for Biologics Evaluation and Research
People: Mary A. Malarkey (Director - - Ex-FDA)
Serena Viswanathan (Associate Director)

Open in Dashboard

ID · 383b87f3-8836-40b3-9c14-e04cfa20293f

Violation Codes10

21 CFR 127121 CFR 1271.3(d)21 CFR 1271.10(a)21 CFR 1271.1521 CFR 1271.10(a)(2)21 CFR 1271.3(c)21 CFR 1271.10(a)(1)21 CFR 1271.3(f)(1)21 CFR 31221 U.S.C. 264

Full citation text and observation details available on the Dashboard.