# FDA 483 - Ethos Emergency Preparedness, LLC - October 07, 2025

Source: https://www.globalkeysolutions.net/records/483/ethos-emergency-preparedness-llc/61ff41c6-4cb6-40a9-bd5c-73cf81536a44

> FDA 483 for Ethos Emergency Preparedness, LLC on October 07, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ethos Emergency Preparedness, LLC
- Inspection Date: 2025-10-07
- Product Type: device
- Office Name: Kansas City District Office
- Summary: Ethos Emergency Preparedness, LLC, a manufacturer and specification developer of medical devices in Saint Louis, MO, was cited for significant quality system deficiencies during an FDA inspection. The inspection revealed a severe lack of established and documented procedures across multiple critical areas, including design control, corrective and preventive actions, unique device identification, acceptance activities, purchasing controls, and document control. These issues indicate a fundamental breakdown in the firm's quality management system for its Class I and II medical devices.

## Related Documents

- [483 - 2025-02-28](https://www.globalkeysolutions.net/records/483/ethos-emergency-preparedness-llc/e0a63402-0467-4f79-8b67-51b800363e09)

## Related Officers

- [Edward E. Lockwood](https://www.globalkeysolutions.net/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.globalkeysolutions.net/companies/ethos-emergency-preparedness-llc/963bc049-c1c1-4591-bee5-571a7ba7c189

Office: https://www.globalkeysolutions.net/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79
