15 Years of FDA Inspection Data: Infographic Up until recently, it has been difficult to get data on FDA inspections. Sure, the FDA publishes aggregate data every year, but what about the granular data on every inspection? Over the past year, we’ve worked to get at this data and published this first infographic focused on FDA inspections. Subscribe to our weekly newsletter for regulatory and quality insights and developments. As you might imagine, the FDA has had a busy 15 years. Over that time period, they conducted 600,000+ inspections spanning 150,000+ facilities, issuing 130,000+ FDA 483s, and utilizing 4,500+ inspectors. THE MIX OF FDA INSPECTIONS HAS CHANGED DRASTICALLY Looking at the inspections year by year, FDA has gradually ramped up the number of inspections each year, starting at around 30,000 in 2000, and peaking at 46,000 in 2011. 483s issued roughly mirrored that trend as well. Inspection duration has roughly stayed at about 3-4 days, though 3.8 days in 2014 was an all-time high. This could potentially be due to the increased focus on international inspections, which have tripled over the last six years. This is possibly the key take-away from this infographic. International inspections remained constant – at around 800-900 from 2000 to 2008. An obvious, intentional shift in strategy began in 2009, which corresponds to a changing of the guard (Commissioner Hamburg took over for Commissioner Eschenback). Nonetheless, this is not a surprise, as the FDA has publicly announced this increased intensity overseas to match the volume of pharmaceuticals manufactured overseas. We have seen this very clearly in our business as well. More and more of our customers are coming from overseas, as they prepare for their FDA inspections, sometimes for the first time. Just last week, customers from Turkey and Taiwan contacted us on the same day. FDA INVESTIGATORS: LOTS OF VETERANS & ROOKIES Looking specifically at the inspector data is also quite interesting. Out of the 4,500 inspectors utilized over the last 15 years, only 1,500 are active. That means 1,500 inspectors have inspected at least one facility in the last 12 months. As we looked at this data, it seemed that many of the inspections from 2000 to 2005 utilized inspectors that only inspected one facility. Perhaps the FDA transitioned strategies to dedicated inspectors as time passed. These active inspectors have inspected an average of 122 facilities. Despite a massive hiring surge of new inspectors, there is still a large contingent of very experienced inspectors in the field – almost 750 inspectors have inspected at least 101 facilities. There are also a lot of “rookies”, with 177 inspectors with 4 or less inspections under their belts. Of course, these rookies are getting mentoring and in-the-field training from their more experienced counterparts. All in all, we expect to see the FDA continue to ramp up international inspections, using their most experienced inspectors to lead those inspections. What do you see in these numbers? All of this data is interesting for an infographic, but the true value lies in the specifics. We have all this granular data about inspections linked with inspectors, sites, 483s, and warning letters.

Comparing and Analyzing Russian, UK, and US Top Ten Pharma Inspection Findings FY 2019

Webinar: Comparing and Analyzing Russian, UK, and US Top Ten Pharma Inspection Findings FY 2019

Presented by Jerry Chapman on October 29, 2020

What you will learn:

  • A comparison of 483 observations in FY2019
  • Top 10 Russian Ministry of Health inspection findings
  • Top 10 FDA Warning Letter findings
  • Top MHRA inspection findings
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STRENGTHEN DATASETS Redica machine intelligence algorithms identify and triage risk signals to derive meaning from vast amounts of private and public data.

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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

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In this summary we identify:

FY2018-FY2020 GMP data for Lonza & Catalent

Top GMP primary citations

Top FDA 483 observations

Panel Discussion – Remote Audits

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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.

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
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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

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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

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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

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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

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Champion of Change - 3Cs to Success

Webinar: Champion of Change - 3Cs to Success

Presented by Steve Greer on June 23, 2020

What you will learn:

  • The 3C Model to become a champion of change
  • How to identify game-changing habits and the steps to implement them
  • Ways to develop greater purpose-centered leadership
  • How to generate awareness along with actions to create changes in how you think about challenges and change putting you on a path to lead change successfully in your organization
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5 GMP Case Studies Report

What You Will Learn from This Report:

The first countrywide import alert issued by FDA

An inadequate deviation investigation

An inadequate product specifications and a product recall

Process validation issues at a CMO

A different perspective on process validation and the culpability of the quality unit

 

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What You Will Learn from This Report:

How a major pharmaceutical company designed a program to train future leaders in quality

An industry-led initiative to advance the state of quality in the pharma industry

A pharma GMP leader’s tips for supporting quality culture within an organization

An update on FDA’s Quality Maturity Model

Impact of the Global Pandemic on Recent Data Integrity and Regulatory Non-compliance Trends

Webinar: Impact of the Global Pandemic on Recent Data Integrity and Regulatory Non-compliance Trends

Presented by Paul Smith, Agilent Technologies on Aug. 26, 2020

What you will learn:

  • Examples of essential laboratory actions to remain compliant during the pandemic
  • Recent data integrity non-compliance findings and trends
  • Essential strategies to find, understand, and leverage regulatory non-compliance data

Past, Present, and Future of Quality Culture

Presented by Regulatory Compliance Associates Distinguished Fellow Susan Schniepp

What you will learn:

  • How the 2014 FDA quality metrics initiative led to greater focus on quality culture
  • New quality culture tools and standards under development by PDA and other organizations
  • Best practices for quality culture, including case studies with lessons learned

Changing Medical Device Regulations

Presented by Redica Systems 

What you will learn:

  • The latest developments regarding the EU MDR
  • Quality Systems requirements for medical devices
  • Regulatory updates affecting medical devices

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Combination Product Report

What You Will Learn from This Report:

The latest U.S. and European regulatory developments

The impact of smart combination products

How the EU MDR impacts drug-device combination products

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5 GMP Case Studies Report

What You Will Learn from This Report:

In-depth analysis of the findings

Lessons learned

How companies can avoid similar shortcomings.

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Redica Systems Expert Jerry Chapman to Present at SQA Annual Meeting

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.

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Find out what information to include

Review correspondence between sponsor and FDA

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A.I. for Quality and Compliance Teams

August 3 webinar

Presented by Redica Systems Senior GMP Quality Expert Jerry Chapman

What you will learn:

  • A basic understanding of data sources, machine learning, NLP, and A.I. tools
  • Building and applying Expert Models
  • Two case studies, one on sterile manufacturing/503B and one on data integrity
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Get the scoop on recent data integrity 483 observations!

  • FY 2020 Data Integrity 483 Observations
  • Data Integrity Observations for Human Drugs
  • Observations Falling Under GMP
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Human Factors – Compliance and Applications

June webinar

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

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

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