# FDA WARNING_LETTER - PurePurge Inc. - June 02, 2021

Source: https://www.keypedia.com/records/warning_letter/purepurge-inc/d5b2a82d-3add-4791-a02d-de4ace574fad

> FDA WARNING_LETTER for PurePurge Inc. on June 02, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: PurePurge Inc.
- Inspection Date: 2021-06-02
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to PurePurge Inc. on June 2, 2021, regarding their MEDPURE HAND SANITIZER product line, marketed via purepurge.com and medpure.store. The FDA determined these products are unapproved new drugs and misbranded.

Violations include:
1. **Unapproved New Drug:** MEDPURE HAND SANITIZERS are considered "drugs" due to their intended use as topical antiseptics, with claims like "reduce bacteria," "kill: Gram Positive Bacteria, Gram Negative Bacteria, Enveloped Viruses, Non-Enveloped Viruses, Fungi, Mold, Spores," and "eliminates 99.99% of viruses and bacteria in as little as 15 seconds." They are "new drugs" because they are not generally recognized as safe and effective (GRASE) and lack FDA approval.
2. **Non-Conformity to TFM:** The products contain isopropyl alcohol 70% and hydrogen peroxide 0.15%, and feature "PurePurge™ Technology," which the FDA identifies as an unlisted active ingredient. Neither hydrogen peroxide nor PurePurge™ is permitted as an active ingredient for consumer antiseptic hand rubs under the 1994 Tentative Final Monograph (TFM) or subsequent amendments, nor do they align with FDA's temporary COVID-19 hand sanitizer policies.
3. **Misbranding (502(

## Related Officers

- [Carolyn E. Becker](https://www.keypedia.com/people/carolyn-e-becker/ad2daae5-dda1-4b9c-a69a-775997e7b60b)

Company: https://www.keypedia.com/companies/purepurge-inc/07db72d7-76f4-4052-9270-255ef55984ee

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