Biologics Inspection Case Studies Highlight API and Drug Product Deficiencies

December 9, 2024
Conference Spotlight

Facility Issues Top Inspection Deficiencies for Biologics

November 12, 2024
Conference Spotlight

Who is Responsible When GMPs Are Not Followed?

October 9, 2024
Conference Spotlight

What is a VAI or OAI Regulatory Meeting?

October 2, 2024
Conference Spotlight

Drug GMP Warning Letter Issued Without Facility Inspection

November 20, 2023
Enforcement

Expert Commentary | Updates to FDA’s Manual of Policies and Procedures (MAPP)

July 12, 2023
Conference Spotlight

FDA on the Evolution of Biologics Inspections: Part II

December 6, 2022
Conference Spotlight

Persistent Non-Compliance Leads to a Consent Decree

October 27, 2022
Conference Spotlight

Senior Management Failures Lead to Patient Deaths, Prison Sentence

October 25, 2022

Why am I Being Inspected Again So Soon After a Pre-Approval Inspection?

October 6, 2022
Conference Spotlight

Five FDA Warning Letters Issued in Four Years for Fraudulent Cancer Drug

July 14, 2022

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