# FDA WARNING_LETTER - Prefense LLC - April 06, 2020

Source: https://www.globalkeysolutions.net/records/warning_letter/prefense-llc/89b28576-e80b-4b2c-a4be-c4b8b534108a

> FDA WARNING_LETTER for Prefense LLC on April 06, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Prefense LLC
- Inspection Date: 2020-04-06
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On April 23, 2020, the FDA issued a Warning Letter to the company operating www.prefense.com, www.safety-med.com, www.mdsassociates.com, and www.apollosafetyproducts.net, following a review on April 6, 2020. The letter addresses the sale of "Prefense Hand Sanitizers" with unapproved claims related to COVID-19 and other diseases.

The FDA determined that Prefense Hand Sanitizers are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. § 355(a), and their introduction into interstate commerce is prohibited by section 301(d), 21 U.S.C. § 331(d). The products are marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19, which establishes them as drugs under 21 U.S.C. § 321(g)(1)(B) and (C).

These products are considered new drugs because they are not generally recognized as safe and effective (GRASE) for their intended uses. No FDA-approved applications exist for Prefense Hand Sanitizers, and no adequate clinical studies support their GRASE status.

Furthermore, the products do not conform to the 1994 Tentative

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)

Company: https://www.globalkeysolutions.net/companies/prefense-llc/3a447cc7-abac-406c-b2d6-cdbbf60e12e9

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