How to Prepare for an FDA Inspection: 4 Posts

Is your company ready for your next FDA inspection, onsite or virtual?

Last May, Steven Niedelman, Lead Quality Systems and Compliance Consultant to the FDA & Life Sciences practice team at King & Spalding law firm presented a webinar on FDA inspections for Redica Systems (then Govzilla) titled, “Guess Who’s Knocking at Your Door: Assuring Inspection Success!”

We summarized his talk into four blog posts published last fall. Below are summaries of each along with links. 

Note: While the webinar and related articles concerned onsite inspections, the information is also valuable when faced with a virtual inspection/remote audit.

FDA Inspection Readiness Part I: Knock, Knock, Who’s There? Your Friendly FDA Investigator

Part I provided background on the regulations behind FDA inspections. Plus, Steve explained what you should do when an inspection of your site has been announced.

FDA Inspection Readiness Part II: Why Your FDA Inspection History is Important

Part II covered the different types of FDA inspections and why a site’s inspection history can impact future inspections. Steve also explained the three main types of inspections.

FDA Inspection Readiness Part III: The FDA Inspection Has Begun, Now What?

Learn what to expect during an inspection in Part III. Steve also detailed how to prepare in advance for an inspection.

FDA Inspection Readiness Part IV: The FDA Inspection is Over, What Happens Next?

In Part IV, Steve described what to expect following an inspection and explained how to respond to FDA 483 observations.

How to Prepare for a Virtual Inspection

In addition to the four posts above, Redica Systems Senior GMP Quality Expert Jerry Chapman has covered preparing for virtual inspections in his Conference Spotlight posts.

• Yes, FDA is Still Performing Pharma Inspections, Using Risk-Based Criteria: What is Your Risk for Inspection?
• Preparing for a Virtual FDA Inspection: Advice from Former FDA Investigator and Investigations Director Ricki Chase
• Hosting a Virtual FDA Inspection: Advice from Former FDA Investigator and Investigations Director Ricki Chase