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

Source: https://www.keypedia.com/records/warning_letter/pa-green-wellness-llc/383b87f3-8836-40b3-9c14-e04cfa20293f

> FDA WARNING_LETTER for pa green wellness llc  on August 17, 2020. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: pa green wellness llc 
- Inspection Date: 2020-08-17
- Product Type: Biologics
- Office Name: Center for Biologics Evaluation and Research
- Summary: 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

## Related Officers

- [Director -  - Ex-FDA](https://www.keypedia.com/people/mary-a-malarkey/11b99e21-5f75-4b61-83bc-d140e35e4dae)
- [Associate Director](https://www.keypedia.com/people/serena-viswanathan/7d1b292d-1f22-42ff-8452-0bc9673b8326)

Company: https://www.keypedia.com/companies/pa-green-wellness-llc/5f02bb90-3b7e-4e0e-a0dc-d3d773b25369

Office: https://www.keypedia.com/offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d