483

Trends

FDA Increased For-Cause Inspections Almost 250% in 2025

November 12, 2025

Trends

Non-Sterile Doesn’t Mean Low Risk: FDA Emphasizes Gaps in Microbial Control

October 27, 2025

Enforcement

Granules India FDA 483 Includes Potential Contamination and Data Integrity Findings

November 26, 2024

Trends

How Much Can Poor Quality Cost You?

November 8, 2024

Enforcement

FDA Inspection Shows Systemic Data Falsification Issues

October 11, 2024

Conference Spotlight

We Received a 483 After an FDA Inspection – Now What?

May 23, 2024

Enforcement

Expert Commentary: FY2022 Report on the State of Pharmaceutical Quality

June 29, 2023

Trends

Redica Responds: What are Common Laboratory Inspection Findings?

May 1, 2023

Beyond Data Integrity: Ulrich Köllisch on Building a Culture for Tomorrow’s High-End Data Tools

March 14, 2023

Conference Spotlight

Should ICH Tackle Standard Development for CGT Products?

March 8, 2023

Conference Spotlight

Who Decides if my FDA Inspection is Classified OAI?

September 29, 2022

Redica Responds: How Many GMP Inspections Have Resulted in a 483?

September 14, 2022

Trends

PAIs and 483 Issuance Risk: The Trends Are Not What They Seem

September 8, 2022

Redica Responds: Do You Know Where Your Quality Unit Is?

September 7, 2022

Redica Responds: Insights on Media Fill Enforcement Trends

August 24, 2022

Redica Responds: Deviation Investigation 483 Trends

August 17, 2022

Redica Responds: Cleaning Validation 483 Observations

August 3, 2022

Redica Responds: Repeat Observations by Region

July 27, 2022

Redica Responds: How Many Change Control 483s Over the Last Ten Years?

July 20, 2022

Redica Responds: Contamination Control 483s

July 13, 2022

Medical Device UDI Requirements: What You Need to Know

July 13, 2022

Conference Spotlight

The Components of “Responsibilities of the Investigator” Observations

June 9, 2022

Conference Spotlight

Data Integrity and Your Clinical Investigator: What the Data Shows

May 26, 2022

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