# FDA 483 - NATURE'S FUSIONS, LLC - January 21, 2025

Source: https://www.keypedia.com/records/483/natures-fusions-llc/39a41674-7280-4cba-9a54-6340d70170a0

> FDA 483 for NATURE'S FUSIONS, LLC on January 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NATURE'S FUSIONS, LLC
- Inspection Date: 2025-01-21
- Product Type: drugs
- Office Name: Denver District Office
- Summary: NATURE'S FUSIONS, LLC in Orem, UT was inspected and cited for multiple significant deficiencies in its manufacturing processes for OTC hand sanitizers. The observations primarily concern inadequate quality control, lack of proper stability data for expiration dates, deficient testing of components and finished products for microorganisms and identity, and improper storage conditions. These issues indicate a severe lack of adherence to cGMP requirements, potentially impacting product quality and safety.

## Related Documents

- [WARNING_LETTER - 2025-01-21](https://www.keypedia.com/records/warning_letter/natures-fusions-llc/9e492883-51f9-4cd4-8f99-e15717677b41)

## Related Officers

- [Carolina D. Vasquez](https://www.keypedia.com/people/carolina-d-vasquez/ffa9d542-e660-4575-831e-f11a2de4b978)

Company: https://www.keypedia.com/companies/natures-fusions-llc/15232334-7744-4d1c-a89c-120b785cde3a

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face