# FDA WARNING_LETTER - Strategia Project Management, Inc. - September 28, 2021

Source: https://www.keypedia.com/records/warning_letter/strategia-project-management-inc/578c4691-adc0-4bc9-98e7-24b2bd475f46

> FDA WARNING_LETTER for Strategia Project Management, Inc. on September 28, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Strategia Project Management, Inc.
- Inspection Date: 2021-09-28
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On September 28, 2021, the FDA issued a Warning Letter to microSURE regarding their unapproved new drug products related to COVID-19. The FDA reviewed microSURE's websites (microsure.com, microsure.com/shop) and social media (Twitter, Facebook) and found they offered a non-alcohol-based topical antiseptic product, microSURE Hand Sanitizer, with claims to mitigate, prevent, treat, diagnose, or cure COVID-19 and other serious infections.

The FDA determined this product is an unapproved new drug, violating section 505(a) of the FD&C Act, and a misbranded drug under sections 502(a) and (ee). Claims such as testing against SARS-CoV-2, destroying viruses, and eradicating bacteria and viruses establish its intended use as a drug. The product is considered a "new drug" because it is not generally recognized as safe and effective (GRASE) for its claimed uses. No FDA-approved applications are in effect for this product.

Furthermore, while the product lists benzalkonium chloride as an active ingredient, claims about silica dioxide forming a crystalline layer to eradicate bacteria and viruses indicate silica dioxide is also an active ingredient. Silica dioxide is not a permitted active ingredient for consumer antiseptic hand rub products under the 1994 TFM. The product's claims of effectiveness against SARS-CoV-2

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

Company: https://www.keypedia.com/companies/strategia-project-management-inc/4bc24e0c-e9da-4ebf-917c-9f5948b2697f

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