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Jerry Chapman
Principal, Quality Data & Analytics
category
FDA PreCheck Initiative Draws Strong Industry Reaction at Recent Stakeholder Meeting
December 1, 2025
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FDA: A Pillar of Protection for Patients and Industry
April 4, 2025
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Limiting Plant Access and Sharing Redacted Documents Results in Import Alert and Warning Letter
January 28, 2025
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Biologics Inspection Case Studies Highlight API and Drug Product Deficiencies
December 9, 2024
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Granules India FDA 483 Includes Potential Contamination and Data Integrity Findings
November 26, 2024
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MedTech 2024 Highlights: A Look at iCGM Systems and CPAP Machines
November 25, 2024
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Facility Issues Top Inspection Deficiencies for Biologics
November 12, 2024
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FDA Inspection Shows Systemic Data Falsification Issues
October 11, 2024
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Who is Responsible When GMPs Are Not Followed?
October 9, 2024
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What is a VAI or OAI Regulatory Meeting?
October 2, 2024
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FDA Investigator Attrition Rate Addressed at 2024 PDA/FDA Conference
September 11, 2024
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A Glimpse into the Thought Processes of an FDA Expert Investigator
August 28, 2024
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Homeopathic Product for Infants Contaminated with Bacteria and Cancer-Causing Lubricant
July 23, 2024
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Blatant Data Manipulation and Password Sharing Still Taking Place
June 6, 2024
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We Received a 483 After an FDA Inspection – Now What?
May 23, 2024
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Infusion Product with TNTC Bioburden Released to the Market
May 20, 2024
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How AI Can Reveal Enforcement Trends in Data Integrity
April 25, 2024
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A New Drug GMP Mutual Recognition Agreement Model
April 24, 2024
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