# FDA 483 - Emilia Resources, LLC - August 09, 2019

Source: https://www.globalkeysolutions.net/records/483/emilia-resources-llc/f65acc30-3e2a-4243-b370-9f363a074afc

> FDA 483 for Emilia Resources, LLC on August 09, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Emilia Resources, LLC
- Inspection Date: 2019-08-09
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Emilia Resources, LLC, an OTC drug manufacturer in De Kalb, MS, revealed significant deficiencies across multiple areas of their operations. The firm failed to validate manufacturing processes, lacked adequate computer system controls, and did not thoroughly investigate batch failures or ensure proper product release testing. Additionally, issues were noted with supplier qualification and the completeness of annual product reviews.

## Related Documents

- [483 - 2019-06-18](https://www.globalkeysolutions.net/records/483/emilia-resources-llc/6efe1aa9-661c-4d45-abf5-43bf3886a8ea)

## Related Officers

- [Susan O. Oladeji](https://www.globalkeysolutions.net/people/susan-o-oladeji/307277f8-7704-4ada-8d8d-d77118c6cb77)

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

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7