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New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483s

August 29th 2025

The authors examine common FDA 483 findings and outline strategies to address and prevent regulatory non-compliance.

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Keeping Audit and Inspection Programs Current

September 2nd 2024

Cancer Question | Image Credit: ©freshidea - Stock.adobe.com
Post-Warning Letter Interaction with FDA

July 1st 2024

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FDA Releases Facility Readiness Guidance

June 21st 2024

Cancer Question | Image Credit: ©freshidea - Stock.adobe.com
Are You Ready for Inspection?

January 1st 2024

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