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

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Mark Agostino
Michael de la Torre
Rebecca Stauffer
Redica Systems
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Regular posts covering guidance changes, inspection findings, data methodology, and Redica product updates.
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Conference Spotlight

FDA: A Pillar of Protection for Patients and Industry

April 4, 2025
Jerry Chapman
FDA
FDA Oversight
Patient Safety
Enforcement

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

January 28, 2025
Jerry Chapman
FDA
import alert
Inspection
Tianjin Darentang Jingwanhong
Tianjin Darentang Jingwanhong Pharmaceutical

Strategies to Improve Your CAPA Program: Addressing Key Compliance Risks

January 24, 2025
Jackie Torfin
CAPA
CAPA System

What Is a 510(k) Submission? A Complete 2025 Guide

January 14, 2025
Redica Systems
510k
510k submission

503B Outsourcing Facilities: A Complete 2025 Inspection-Readiness Guide

January 8, 2025
Redica Systems
503A
503B
503B outsourcing

Redica Systems Successfully Completes SOC 2® Audit

December 17, 2024
Redica Systems
No items found.

Biologics Inspection Case Studies Highlight API and Drug Product Deficiencies

December 9, 2024
Jerry Chapman
API
Case Study
CDER
FDA

Understanding MHRA UK Compliance in Pharma and MedTech

December 4, 2024
Redica Systems
No items found.

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

November 29, 2024
Redica Systems
FDA
FDA Database
Enforcement

Granules India FDA 483 Includes Potential Contamination and Data Integrity Findings

November 26, 2024
Jerry Chapman
483
483 Findings
Data Integrity
Form 483
Granules India
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

Addressing FDA’s Biggest Challenges

November 15, 2024
Scott Sherrill
China
Drug Shortages
FDA
FOIA
import alert

Tianish Laboratories Private Limited: A Timeline of Regulatory Assessments

November 13, 2024
Redica Systems
No items found.
Conference Spotlight

Facility Issues Top Inspection Deficiencies for Biologics

November 12, 2024
Jerry Chapman
BLAs
CDER
OPMA
OPQ
PDA/FDA
Trends

How Much Can Poor Quality Cost You?

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

Navigating FDA Guidelines for Combination Products: A Comprehensive Guide

November 6, 2024
Redica Systems
Combination Products
FDA Database
FDA Approval
Guidelines
medical devices

KVK-Tech Warning Letters: A Timeline of Regulatory Assessments

October 30, 2024
Redica Systems
No items found.

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