It has often been said that “the best defense is a good offense.” Believe it or not, this can also be applied to FDA inspections.

“How?” You may ask as the security guard alerts you to FDA Investigator Peter Baker standing outside the gate holding a form 482 announcing an inspection. 

(Peter Baker is no longer with FDA but for the purposes of this post, we will pretend he is still an FDA investigator. To learn more about how Redica Systems can help with inspection readiness, click here.)

 

As you scramble to get your team together, you try to think of discussion points before this hasty meeting. Fortunately, Redica Systems offers data on hundreds of FDA investigators. This can give your team a complete inspection history for your investigator. 

Quickly, you open Redica and begin researching Peter Baker using the following five tips.

1. Start with the Metrics

  • How experienced is your FDA investigator?
  • How tough are they—what is their 483 issuance rate for companies like yours?
  • How many Warning Letters have resulted from inspections they conducted?
  • Who have they inspected in the last year and what have been the results of the inspections?

After searching Peter Baker by name, you pull up the results using the list view. Here he is at the top of the list.

2. Get a History Lesson

Click Peter Baker’s name. This gives you his inspection history as an FDA investigator. From his history, we learn he has primarily conducted inspections in China. Previously, he inspected sites in India. His concentration is Human Drugs and he appears to focus on data integrity.

3. Review Enforcement Actions

Continue looking at Peter Baker’s inspection history. Fully review his most recent enforcement activities. What does he tend to focus on? Which categories does his 483 observations fall under? Take advantage of our new tagging capabilities.

As mentioned above, he tends to hone in on data integrity. This means you can expect him to ask a lot of questions about data controls and even look through your manufacturing and quality online systems. He will also want to review test data to ensure your site is following good data integrity practices by not conducting retests nor hiding bad test data.

Of course, your site should not be doing that anyway!

4. Filter For the Info You Want

For deeper analysis, filter down. Is your site based in a specific region and produces primarily a specific product? Use these as filters. You can also filter by time frame.

For example, if your site is in the Asia-Pacific region and produces a sterile injectable, you can filter Enforcement Actions in these areas. Perhaps you only want to see his inspections in the last three years. You will now have a list of Peter Baker’s inspections in this region and in this category for the past three years.

5. Go Beyond Redica Systems

We want you to use our system. We are proud of our Enforcement Analytics. Our data is strong. Yet it also would not hurt to do some additional outside research. Contact your colleagues who have been inspected by Peter Baker. Check out his LinkedIn page.

This information will give you a clearer picture of who he is. 

Now that you have done your homework, you have a sense of what to expect in your FDA investigation! Continue to use Enforcement Analytics throughout your inspection process as well.

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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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In this summary we identify:

FY2018-FY2020 GMP data for Lonza & Catalent

Top GMP primary citations

Top FDA 483 observations

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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

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.

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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

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

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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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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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