# FDA 483 - EO Products, LLC - October 23, 2025

Source: https://www.keypedia.com/records/483/eo-products-llc/07a7f16c-4c01-4350-b0a4-c21f53762115

> FDA 483 for EO Products, LLC on October 23, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EO Products, LLC
- Inspection Date: 2025-10-23
- Product Type: drugs
- Office Name: San Francisco District Office
- Summary: An FDA inspection of EO Products, LLC in San Rafael, CA, revealed significant deficiencies across multiple systems. The firm failed to conduct adequate investigations into out-of-specification results and customer complaints, lacked validated testing methods and long-term stability studies, and exhibited inadequate control over component testing, in-process sampling, equipment calibration, and facility segregation. These issues indicate a systemic failure to adhere to cGMP requirements for OTC drug manufacturing.

## Related Documents

- [483 - 2020-11-17](https://www.keypedia.com/records/483/eo-products-llc/60579d6d-d3fd-4689-bbc6-6e9ba5086919)
- [483 - 2025-10-23](https://www.keypedia.com/records/483/eo-products-llc/fe54de22-3342-48a9-80dc-18bedc74d33c)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/ngozi-g-offor/d9d0aa28-6bd1-4427-a712-8716c96b1f3d)

Company: https://www.keypedia.com/companies/eo-products-llc/5ca6500c-60f8-43a0-a6b6-cde349d9dd77

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df