Govzilla’s Top 20 Posts of All Time

Over the years, the Govzilla blog published over 725 articles covering a breadth of topics including:

And, more.

To serve as a resource for you and your company and to help orient you to the scope of the Govzilla blog, we assembled a list of some of our most useful, relevant, and popular articles of all time.

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  1. The FDA And MHRA’s Most Recent Drug Inspection Observations: A comprehensive GMP Intelligence program includes monitoring of health authority enforcement actions.
  2. The Ultimate Guide To Form FDA 483s: Go beyond the basics of the Form FDA 483 and learn all you need to know.
  3. Data Integrity Trends In 483s And Warning Letters: Part 1: The FDA cited data integrity on 79% of drug Warning Letters over the last 5 years.  If you cannot trust the data of the process and its results, then can you really trust anything?
  4. FDA: How Pharma Companies Are Unknowingly Introducing Risk Into Their Quality Management Systems: Consumer Safety Officer Emilie Kahn shares her take on the increased risk that companies are unknowingly introducing into their quality risk management (QRM) systems.
  5. FDA Cites Part 11 In Clinical Trial – We all “know” FDA doesn’t cite Part 11 in 483s, right?  Well, maybe.
  6. 28 Unique Data Integrity Deficiencies That Aren’t Really Unique – See specific data integrity citations from over the years that may not be as new as you think.
  7. Top 10 Responsibilities Of The Pharma Quality Unit – We compiled this list from FDA regulations and guidance documents that define the job of the Quality Unit.  After all, the Quality Unit is the only job description that appears in the Code of Federal Regulations!
  8. 5 Features to Look For in an EIR – An EIR provides a wealth of information regarding the site, conduct, and outcome of an inspection.  It is particularly useful for firms to understand what areas the FDA focuses on and how the FDA reviews documents.
  9. 10 Ways For Small And Virtual Companies To Prepare For A GMP Inspection – Following are our 10 suggestions for these firms to ensure a successful inspection outcome when they have limited experience in this activity and limited resources.
  10. Why Did McKesson Receive The First DSCSA Warning Letter? – First-of-a-kind enforcement actions are always of interest in terms of what they tell us about the FDA’s potential future enforcement in an area.
  11. MHRA’s “Right Environment” – Former FDA Investigator Peter Baker explains his belief that Quality Culture and data integrity are intrinsically connected based on MHRA’s concept of “right environment”.
  12. The Ultimate Guide To Researching Your FDA Inspector – Are you fully inspection-ready without knowing anything about your inspector?  We walk through 8 steps to help you and your team prepare before your inspector arrives.
  13. Repeat Deficiencies In Lupin Limited Warning Letters: Lupin Limited (India) came up short on both taking a global view to remediation as well as addressing issues at all sites.
  14. Identification Of Software Validation Shortcomings: Why doesn’t FDA commonly cite ‘lack of software validation’ as a deficiency” to drug manufacturers? 
  15. How To Talk So That FDA Will Listen, And How To Listen When They Talk: Advice That Could Be Worth Millions: Having a strong data package including extensive product and process knowledge is critical to getting a new drug approved, but by itself may not be enough. 
  16. COVID-19 Pandemic And Your GMP Audit Schedule For 2020:  Bottom line, supply chain issues will be with us in unexpected ways during this public health crisis. Take a look at the GMP audit program and some options that may be able to help mitigate risk in this area.
  17. Overview: 2018 MHRA GMP Inspection Deficiencies: This article provides a high-level overview of the 2018 data, and we will do a later follow-up report including additional granularity and trends over the past few years.
  18. CDER Warning Letter Trends By Facility Type: Recently, the CDER warning letter issuance skyrocketed from 70 in FY2014 to 128 in FY2018, an increase of 83%. What types of firms are taking the heat? And where are they located?
  19. FDA Expanding Its Sterile Drug NIPP Inspection Pilot To Include Other Dosage Forms:  Alonza Cruse explains that the pilot phase for NIPP for inspections of sterile drug products has concluded, and FDA will be using the model for inspections of other drug product types.
  20. Deep Pockets | Does The FDA Get Tougher If The Owner Gets Richer?: We provide five recent examples where the FDA appears to increase their enforcement intensity when an acquiring firm with perceived ‘deep-pockets’ enters the game.

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