# FDA 483 - Emilia Resources, LLC - June 18, 2019

Source: https://www.globalkeysolutions.net/records/483/emilia-resources-llc/6efe1aa9-661c-4d45-abf5-43bf3886a8ea

> FDA 483 for Emilia Resources, LLC on June 18, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Emilia Resources, LLC
- Inspection Date: 2019-06-18
- Product Type: device
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Emila Resources, LLC, a medical device manufacturer in De Kalb, MS, revealed significant deficiencies in their quality system. The firm failed to establish written procedures for Medical Device Reporting (MDR), complaint handling, and purchasing control. These observations indicate a fundamental lack of documented processes essential for ensuring product quality and regulatory compliance.

## Related Documents

- [483 - 2019-08-09](https://www.globalkeysolutions.net/records/483/emilia-resources-llc/f65acc30-3e2a-4243-b370-9f363a074afc)

## Related Officers

- [Nicholas Z. Lu](https://www.globalkeysolutions.net/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)

Company: https://www.globalkeysolutions.net/companies/emilia-resources-llc/860d4bab-6ee6-4d37-ab92-1bf3bfe4539c

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea