# FDA RESUME - Unknown Company - Unknown Date

Source: https://www.globalkeysolutions.net/records/resume/unknown-company/e22f7781-b612-4811-a8c7-7de7dc6a8b49

> FDA RESUME for Unknown Company on Unknown Date. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: RESUME
- Summary: Donna D. Gallien, a Consumer Safety Officer/Investigator with the U.S. Food and Drug Administration (FDA) based in Nashville, Tennessee, has over 25 years of experience. She has independently conducted more than 600 inspections and investigations across several U.S. states and internationally, including countries like Canada, Brazil, Germany, Italy, and Spain. Her work primarily involves BioResearch establishments, focusing on compliance with Current Good Manufacturing Practices (CGMP) to ensure consumer safety and efficacy.

Gallien's role requires advanced skills in analyzing complex scientific and technical evidence. She is responsible for planning and executing thorough investigations, preparing detailed inspection reports, and communicating findings to management. Her recommendations often lead to voluntary actions and regulatory considerations based on the evidence collected.

In addition to her investigative duties, Gallien provides on-site training for new investigators, sharing her expertise and techniques. Her educational background includes a Master's degree in Public Health from Tulane University and a Bachelor's degree in Public Health from Dillard University, with coursework in epidemiology, infectious diseases, and environmental health science.

The document does not specify any particular violations or required actions but highlights Gallien's role in assessing compliance and recommending actions based on her findings. Her work aligns with the FDA's regulatory framework, ensuring adherence to CGMP and safeguarding public health.

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## Related Officers

- [Consumer Safety Officer/Investigator](https://www.globalkeysolutions.net/people/donna-d-gallien/3b5d4a2b-4c8b-4618-a986-3a23c12faad4)