# FDA WARNING_LETTER - Vibrant Health Care, Inc. - November 18, 2020

Source: https://www.keypedia.com/records/warning_letter/vibrant-health-care-inc/2eed23ec-bd4e-4932-8b29-88e0ff0c2488

> FDA WARNING_LETTER for Vibrant Health Care, Inc. on November 18, 2020. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Vibrant Health Care, Inc.
- Inspection Date: 2020-11-18
- Product Type: Biologics
- Office Name: Center for Biologics Evaluation and Research
- Summary: The FDA and FTC issued a Warning Letter to Vibrant Health Care, Inc. on November 18, 2020, following a review of their website and social media in November 2020. The company was found to be offering an umbilical cord-derived cellular product in the U.S. to mitigate, prevent, treat, diagnose, or cure COVID-19.

The product is classified as a human cell, tissue, or cellular or tissue-based product (HCT/P) under 21 C.F.R. § 1271.3(d). However, it 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 the homologous use criterion in 21 C.F.R. § 1271.10(a)(2). Consequently, the product is deemed an unapproved new drug under section 505 of the FD&C Act (21 U.S.C. § 355) and a misbranded drug under section 502 (21 U.S.C. § 352). It is also an unlicensed biological product under section 351 of the PHS Act (42 U.S.C.

## 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/vibrant-health-care-inc/0599e82b-1c3e-4d5f-a399-074b98e4dd67

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