Former FDA Investigator & Deputy Director, Investigations Branch
Marianne Allen
Spent 25+ years inspecting pharmaceutical, biologics, bioresearch, device and food manufacturers, and served as Deputy Director of an Investigations Branch.
- Inspections
- CAPA
- FD-483
- Biologics
- Food
25+ years inspecting FDA-regulated manufacturers
Background
Marianne Allen is a former (retired) FDA Investigator who spent more than 25 years inspecting pharmaceutical, biologics, bioresearch (BIMO), medical device and food manufacturers. In addition to her work as an Investigator, she held the position of Deputy Director of Investigations Branch.
Marianne has particular expertise in assessing compliance issues and implementing appropriate corrective actions, and in responding to FD-483 observations and Warning Letters.
What Marianne does on an engagement
- Compliance assessment across drug, biologic, device and food operations
- CAPA design and implementation
- FD-483 and Warning Letter response
- Investigator-perspective quality system review
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