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Regular posts covering guidance changes, inspection findings, data methodology, and Redica product updates.

Redica Expands Global Inspection Coverage with New PMDA, Swissmedic, EMA, and MFDS Data
Company News

Redica Expands Global Inspection Coverage with New PMDA, Swissmedic, EMA, and MFDS Data

January 28, 2026
Scott Sherrill
featured

Latest Blog Posts

FDA Inspection Database: An Essential Tool to Prepare for FDA Inspections

November 29, 2024
FDA
FDA Database
Enforcement

Granules India FDA 483 Includes Potential Contamination and Data Integrity Findings

November 26, 2024
483
483 Findings
Data Integrity
Form 483
Granules India
Trends

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

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

Using CGMP Site Risk Scores to Predict Drug Shortages

November 22, 2024
CGMP
Drug Shortages
FDA
Predict Drug Shortages
Redica Systems

Addressing FDA’s Biggest Challenges

November 15, 2024
China
Drug Shortages
FDA
FOIA
import alert

Tianish Laboratories Private Limited: A Timeline of Regulatory Assessments

November 13, 2024
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Company news

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Company News

Redica Expands Global Inspection Coverage with New PMDA, Swissmedic, EMA, and MFDS Data

January 28, 2026
Company News

Redica Systems Announces $30M Series B

December 9, 2021

Conference Spotlight

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Conference Spotlight

FDA: A Pillar of Protection for Patients and Industry

April 4, 2025
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

Enforcement

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Enforcement

Limiting Plant Access and Sharing Redacted Documents Results in Import Alert and Warning Letter

January 28, 2025
Enforcement

Granules India FDA 483 Includes Potential Contamination and Data Integrity Findings

November 26, 2024
Enforcement

Navigating FDA Guidelines for Combination Products: A Comprehensive Guide

November 6, 2024
Enforcement

ICH Q9 Quality Risk Management in Pharma

October 15, 2024

Inspection Intelligence

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Post-market Intelligence

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Post-Market Intelligence

FDA PreCheck Initiative Draws Strong Industry Reaction at Recent Stakeholder Meeting

December 1, 2025

Product News

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Regulatory Intelligence

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Site Intelligence

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Alison Sathe
Anders Vinther
Arijit Saha
Ayan Ghosh
Barbara W. Unger
Jackie Torfin
Jerry Chapman
Jon Falker
Katie Terry
Mark Agostino
Rebecca Stauffer
Redica Systems
Roger Angarita
Sarah Boynton
Sarah Kotler
Scott Sherrill
Yelena Ionova
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