# FDA WARNING_LETTER - Predictive Biotech - August 17, 2020

Source: https://www.keypedia.com/records/warning_letter/predictive-biotech/4261adfe-c68d-411a-94ce-3dc880d313c9

> FDA WARNING_LETTER for Predictive Biotech on August 17, 2020. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Predictive Biotech
- Inspection Date: 2020-08-17
- Product Type: Biologics
- Office Name: Center for Biologics Evaluation and Research
- Summary: On August 17, 2020, the FDA issued a Warning Letter to Predictive Biotech, Inc. for marketing CoreCyte™, an umbilical cord-derived product, as a treatment, preventative, diagnostic, or cure for COVID-19. The FDA reviewed the company's websites (www.predictivebiotech.com, https://predtechgroup.com) and social media (www.facebook.com/PredictiveBiotech/) in August 2020.

CoreCyte™ is classified as a human cell, tissue, or cellular or tissue-based product (HCT/P) but fails to meet the criteria for regulation solely under section 361 of the PHS Act (42 U.S.C. § 264) and 21 C.F.R. Part 1271. Specifically, it does not qualify for homologous use (21 C.F.R. § 1271.10(a)(2) and 21 C.F.R. § 1271.3(c)) and appears to exceed minimal manipulation (21 C.F.R. § 1271.10(a)(1) and 21 C.F.R. § 1271.3(f)(1)).

Consequently, CoreCyte™ is deemed an unapproved new drug

## Related Officers

- [Director -  - Ex-FDA](https://www.keypedia.com/people/mary-a-malarkey/11b99e21-5f75-4b61-83bc-d140e35e4dae)

Company: https://www.keypedia.com/companies/predictive-biotech/4d36e6fb-c174-49f2-a64c-3a6d0997e362

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