# FDA WARNING_LETTER - Salvacion USA Inc. - February 20, 2024

Source: https://www.keypedia.com/records/warning_letter/salvacion-usa-inc/22869b9d-095b-4737-87fc-8f205f47eaf9

> FDA WARNING_LETTER for Salvacion USA Inc. on February 20, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Salvacion USA Inc.
- Inspection Date: 2024-02-20
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On February 13, 2024, the FDA issued a Warning Letter to Mr. Hwang concerning the distribution of Covixyl Nasal Spray. The FDA reviewed the firm's website (https://covixyl.com/) and social media pages (https://twitter.com/gocovixyl, https://www.facebook.com/covixyl) on October 10, 2023.

The FDA determined that Covixyl Nasal Spray is an unapproved new drug, violating sections 505(a) and 301(d) of the Federal Food, Drug, & Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). The product is classified as a drug under section 201(g)(1)(B) and/or 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(B) and 321(g)(1)(C), due to claims indicating its intended use for disease diagnosis, cure, mitigation, treatment, prevention, or to affect body structure/function.

Examples of violative claims include: "Covixyl® was developed to safely and effectively create a barrier in the nasal passages that helps block airborne viruses, keeping you

## Related Officers

- [Director](https://www.keypedia.com/people/tina-smith/5d590654-a270-4f3f-833f-d6fe13ca8c05)

Company: https://www.keypedia.com/companies/salvacion-usa-inc/0978fecf-f071-4c77-bf46-c925d9379b9f

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c