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

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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)

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

Violation Codes10

42 U.S.C. 262(a)(3)21 U.S.C. 26421 CFR 127121 CFR 1271.10(a)(2)21 U.S.C. 355(i)21 U.S.C. 331(k)FD&C Act 50221 U.S.C. 35521 CFR 1271.3(f)(1)21 CFR 1271.10(a)(1)

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