# FDA 483 - Ekcomed LLC - August 08, 2019

Source: https://www.globalkeysolutions.net/records/483/ekcomed-llc/5ddf1940-0a75-4785-8e0a-a9a9a894452f

> FDA 483 for Ekcomed LLC on August 08, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ekcomed LLC
- Inspection Date: 2019-08-08
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Ekcomed, LLC, a medical device specification developer in Saint Charles, MO, received a Form FDA 483 citing significant quality system deficiencies. The firm lacked established procedures for contamination prevention, adequate supplier quality agreements, and proper investigation of product complaints. Additionally, Ekcomed had no written Medical Device Reporting (MDR) procedures and failed to document employee training.

## Related Documents

- [483 - 2019-09-12](https://www.globalkeysolutions.net/records/483/ekcomed-llc/75ccce59-cf96-4337-81bd-2a6d1e883ce8)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/ekcomed-llc/c5a3cfe3-875b-4bd2-b120-5ae8bae18ea2

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8