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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
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Latest Blog Posts

Trends

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

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

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

September 7, 2022
483
483 observations
quality unit

ALCOA Data-Integrity Principles: A Complete 2025 Guide

September 6, 2022
483 observations
ALCOA
ALCOA-C,
consent decree
EMA

Redica Responds: Top Quality Systems Issues at Medical Device Sites

August 31, 2022
Devices
FDA inspection
quality system
Redica Responds

Regulatory Expectations for Cleaning Validation

August 30, 2022
101
cleaning
cleaning validation
Contamination
Devices

Redica Responds: Insights on Media Fill Enforcement Trends

August 24, 2022
483
aseptic processing
GMP
Pharma
Redica
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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
101
2011 process validation guidance
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