How 483 observations and Warning Letter deficiencies stack up against the industry average
Top 5 cited categories and regulations
A detailed list of Inspections, Enforcement Actions, Documents, and Co-Investigators

A Solution to Common Compliance Challenges

We’ve built the largest dataset of inspection and enforcement documents in the world. Then, we combined it with advanced machine intelligence delivered to you via an intuitive and easy-to-use platform. We source our data through thousands of unique Freedom of Information Act (FOIA) requests and agency monitoring tools, and our proprietary machine learning models combine industry expertise with modern data science approaches.

Lack of Data to develop perspectives and insights?

Redica’s Solution:

Data on all FDA inspected and registered sites since 2000, with more than 350,000 sites and 800,000 inspections.

20x more data than what has been released on FDA.gov—over 30,000 Form 483s, EIRs, Untitled Letters, MDSAP Reports, and 483Rs.

All FDA issued Warning Letters since 2000.

Health Canada GMP and GCP inspections and enforcement since 2012.

MHRA GMP post-inspection reports since 2005.
Image

Disconnected and Unsearchable Agency Data?

Redica’s Solution:

Retyped, linked, and searchable documents.

Thousands of man hours invested in preparing documents for intake into our process and platform.

All inspections, sites, enforcement actions, and documents cross-linked and indexed.

All documents machine-analyzed and then manually reviewed by a trained team member, retyped, and properly formatted to create an accurate, clean digital version.
Image

No Actionable Specifics and Visualizations?

Redica’s Solution:

Everything all in one place with push button reports.

Consolidated, relevant profiles of all sites, organizations, and investigators with profile summary data.

Push button reports that identify the latest trends and discrepancies from agency norms.
Image

No Tagging and Trending of Data?

Redica’s Solution:

Proprietary machine learning models.

Calculated trends by year, agency, geography, site type, and quality system area.

Over 13,000 organization trees that link all sites to organization to parents.

Over 100,000 tagged sites and organizations categories including sterile, API, FDF, CROs, clinical investigators, vaccines, etc.

Expert tagging models for human drug GMP, GVP, GCP, and medical devices that align citations with your quality system documents and SOPs
Image

Full coverage of Industries, GxPs, and Use Cases

Industries

Human Drugs
Biologics
Vaccines
Cell & Gene Therapy
HCT/P
Combo Products
Medical Device
503B Outsourcers
Homeopathic
Animal Health
Food
Cosmetics
Supplements
Herbal Products

Scope

GMP
GCP
GDP
GLP
GVP
RA-CMC
RA-Labeling
RA-Preclinical
RA-Clinical
Pharmacopoeia

Inspection Prep

Latest agency trends and hot items

Specific inspector tendencies

Benchmark to industry

Vendor Quality

Supplier research and vetting

Ongoing supplier motioning

Risk-based vs time-based audits

Audit scope improvement

Site Quality

Inspection management

Support for audit findings and SOPs, CAPAs, and change control

Training support

Compliance & Audit

Support for audit findings

Audit scope improvement using latest agency trends

Comparisons of audit findings to agency citations

Clinical Quality

Research and vetting during study startup (CI, IRB, CRO)

Ongoing vendor monitoring

Audit scope improvement

Start planning for the unexpected

Schedule a live demo with a Redica team member and discover the
resources quality and safety professionals need with full access to the Redica Platform.

Human Factors – Compliance and Applications

June webinar

Presented by Alison Sathe, Founder, Regulatory Mark & Valerie Fenster, Director of Insights and  Human Factors, Kaleidoscope Innovation 

June 29, 1:30 p.m. EST

What you will learn:

  • Human factors strategies from simple drug products to complex surgical devices
  • Primary and secondary labeling development and evaluation for usability
  • Human factors activities from product development to post-market
  • International strategies: expectations for human factors in regulatory submissions in international markets

Panel Discussion – Remote Audits

Panel Discussion opt in image

Featuring Panelists:
—Barbara W. Unger, Unger Consulting, Inc.
—Jerry Chapman, Redica Systems
—Stephanie Gaulding, Pharmatech Associates

Who Will Benefit?
This session will be valuable to GMP quality, regulatory, compliance, and management personnel in FDA-regulated industries who want to have a conversation on remote audits and get to know what is going on in the industry.

Redica Systems Enforcement Analytics

Prepare for your next inspection.

Enter your email address and someone will contact you shortly to explore observations and trends. 

Redica Systems Enforcement Analytics

Prepare for your next inspection.

Enter your email address and someone will contact you shortly to run your custom report.

Redica Systems Enforcement Analytics

Get help choosing the right CRO.

Enter your email address and someone will contact you shortly to customize your insights.

Redica Systems Enforcement Analytics

Compare two companies of your choice.

Enter your email address and someone will contact you shortly to customize your report.

Download the Special Report

Download your copy of THE FDA INSPECTION LANDSCAPE IN MID-2020 AND A LOOK AT VIRTUAL INSPECTION

In this summary we identify:

  • Trend analysis of FDA inspections through mid-2020
  • Strategies for preparing and hosting virtual inspections
  • New technologies to support remote inspections

Download the Special Report

CDMO Comparison opt-in

In this summary we identify:

FY2018-FY2020 GMP data for Lonza & Catalent

Top GMP primary citations

Top FDA 483 observations

Turning Failure into Success

Presented on Tuesday, April 27, 2021 by Steve Greer, Executive Coach, Genesis Assist, and former Quality Leader, Procter and Gamble

What you will learn:

  • How to use the Leadership SOS Model to transform quality culture
  • How to strengthen quality systems to eliminate human error
  • How to generate ideas on how to set your organization up for success for shareholders, FDA, and staff
Redica Systems Enforcement Analytics

Prepare for inspections of Clinical Investigator sites.

Enter your email address and someone will contact you shortly to provide more Clinical Investigator data about your sites.

Redica Systems Enforcement Analytics

Get Full Access to Redica Enforcement Analytics

Enter your email address and someone will contact you shortly to answer all of your questions and get you started.

Quality Management Systems for Small Pharma and Biotech Firms

Webinar: QMS for Small Pharma and Biotech Firms

Presented by Fenton Fong, Founder, Managing Director, & Principal at xCellarate

Get instant access to the webinar video and slides.

What you will learn:

  • Common challenges small pharma firms face when developing a QMS
    Recent enforcement trends involving the Quality Unit
    Impact of the COVID-19 pandemic

Download the Special Report

APAC ad

In this summary we identify:

GMP data from FY2017 to FY2020 for the Asia-Pacific region

Top 3 GMP primary and secondary citations

Top 3 483 observations

Download the Special Report

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

In this summary we identify:

  • Data from 2019 UK MHRA Inspections
  • Trends from 2015, 2016, 2018, and 2019 inspections
  • Conclusions drawn from an analysis of drug inspection data

Experience the Power of Redica Systems

Redica Pro Free

Sign up for your FREE account today and get instant access to:

SEARCH Find the inspection records you want by inspector’s name, company name, site, city, country, etc.

WARNING LETTERS Easily search the largest database of FDA Warning Letters by date, company, FDA office, or subject

SITES Quickly assess inspection records including dates and inspectors across all of your sites

INSPECTIONS Complete list of FDA inspections by date, company, category, and country

Get Complete Access to the Redica Systems Platform

Please submit your email address and one of our team members will contact you shortly to answer all of your questions and get you started with the new Enforcement Analytics platform.

Redica Systems Enforcement Analytics

Prepare for your next inspection.

Enter your email address and someone will contact you shortly to explore enforcement trends. 

Redica Systems Enforcement Analytics

Monitor compliance at your Clinical Investigator sites.

Enter your email address and someone will contact you shortly to get you started.

Experience the Power of Redica Systems

Redica Systems Enforcement Analytics

Let us know who you are and we’ll be in touch to answer all of your questions and get you started.

Redica Systems Enforcement Analytics

Upgrade your CDMO monitoring strategy.

Enter your email address and someone will contact you shortly to get the data and analysis you need.

Redica Systems Enforcement Analytics

Keep up with the latest Regulatory Developments on Clinical Trials

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Save your team valuable time when using External Monitoring.

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Save time and Resources when using External Monitoring.

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Get immediate access to the news that matters to your sites.

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

See how we can help you eliminate yet another spreadsheet.

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Stay ahead of changing regulations.

Enter your email address and someone will contact you shortly to get the data and analysis you need.

Redica Systems Enforcement Analytics

Upgrade your CDMO management strategy.

Enter your email address and someone will contact you shortly to get the reports and analysis you need.

Redica Systems Enforcement Analytics

Compare the enforcement history of your CDMOs.

Enter your email address and someone will contact you shortly to customize your report.

Experience the Power of Redica Systems

Redica Systems Enforcement Analytics

Sign up for your FREE account today and get instant access to Enforcement Analytics.

Redica Systems Enforcement Analytics

Upgrade your inspection strategy.

Enter your email address and someone will contact you shortly to get the reports and analysis you need.

Redica Systems Enforcement Analytics

Upgrade your inspection strategy.

Enter your email address and someone will contact you shortly to get the reports and analysis you need to prepare for your next inspection.

Experience the Power of Redica Systems

Complete the form and one of our experts will reach out to you to schedule a demo and answer questions about our subscription options.

INDEX INFORMATION  Redica consolidates regulatory data in real-time on the single largest database for quality, safety, and compliance intelligence.

STRENGTHEN DATASETS Redica machine intelligence algorithms identify and triage risk signals to derive meaning from vast amounts of private and public data.

ANALYZE & INTERPRET PATTERNS Redica instantly models the customer-specific regulatory risks, trends, and opportunities that stand to fundamentally change compliance operations.

Redica Systems Enforcement Analytics

Evaluate Your CDMOs

Enter your email address and someone will contact you shortly to customize your report.

Redica Systems Enforcement Analytics

Compare the inspection history of your CDMO sites.

Enter your email address and someone will contact you shortly to customize your report.

Discover the power of the most comprehensive database of 483s in existence.

Our database of over 20,000 483s is retyped and tagged, making it easy to create an Observation Report in seconds.

Eliminate days of work and get your FREE personalized 483 Observation Report.