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Trends

FDA Increased For-Cause Inspections Almost 250% in 2025

November 12, 2025
No items found.
483
FDA
FDA inspection
For-cause
For-Cause Inspections
Trends

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

October 27, 2025
Redica Systems
483
Draft Guidance
FDA
Microbial Control
Non Sterile
Trends

FDA Flags Repeat Offender for DEG/EG Testing Failures—Is Your Supply Chain at Risk?

May 15, 2025
No items found.
DEG
DEG-contaminated
DEG/EG
diethylene glycol
EG
Trends

MedTech 2024 Highlights: A Look at iCGM Systems and CPAP Machines

November 25, 2024
Jerry Chapman
2024 highlights
CPAP Machines
FDA
iCGM
iCGM Systems
Trends

Using CGMP Site Risk Scores to Predict Drug Shortages

November 22, 2024
Katie Terry
CGMP
Drug Shortages
FDA
Predict Drug Shortages
Redica Systems
Trends

How Much Can Poor Quality Cost You?

November 8, 2024
Redica Systems
483
483 observation
483 response
Cost of Quality
Quality
Trends

How Redica Systems Goes Further than the FDA Data Dashboard

August 21, 2023
Redica Systems
Comparison report
data
FDA
FDA Dashboard
Redica
Trends

Redica Responds: What are Common Laboratory Inspection Findings?

May 1, 2023
Redica Systems
483
Inspections
laboratory
Quality
Trends

Instant Download: Insights on Quality from FDA Leaders

November 8, 2022
Redica Systems
No items found.
Trends

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

September 8, 2022
Redica Systems
483
deviations
Enforcement Analytics
FDA
pre-approval inspections
Trends

Instant Download | Analysis of 2021 U.S. FDA 483 GMP Observations

May 3, 2022
Barbara W. Unger
No items found.
Trends

Instant Download | Yes, Warehouses Must Comply with Relevant GMPs

March 8, 2022
Redica Systems
No items found.
Trends

Instant Download | FY2020 and FY2021 Drug GMP Warning Letter Analysis

February 11, 2022
Redica Systems
No items found.
Trends

Instant Download | Analysis of COVID-19 Vaccine and Drug 483s

January 25, 2022
Redica Systems
No items found.
Trends

How Small Pharma Firms Can Prepare for a GMP Inspection

June 30, 2021
Redica Systems
No items found.
Trends

Part II: An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

March 24, 2021
Redica Systems
No items found.
Trends

Part I: An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

March 17, 2021
Redica Systems
No items found.
Trends

What is Risk-Based Thinking?

June 4, 2020
Redica Systems
No items found.

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