To Understand Data Integrity, Just Read These 6 FDA 483s

I asked Barb Unger a difficult question, “If you could just pick 6 483s to understand this Data Integrity problem, which 6 would you pick? And why?”  Here is her response.

From Barb:

As we continue to follow the data integrity story, let’s take a look at six (6) forms 483 associated with data integrity that had broad impact throughout the industry or resulted in serious enforcement actions including consent decree agreements. You will see that they are not limited to a single country and many of the observations are similar or exactly the same over a decade.

The industry has clearly struggled with modifying their practices to ensure compliance. Also, all of these inspection cite observations that are included in the predicate rules, and thus do not represent a change in regulations or interpretation of existing requirements. It’s probably impossible to say which are the most ‘important’ and anyone who has been following this saga probably has their own list of favorites! I’ve made every effort to choose ones that each represent a different area of focus. These are in no particular order except for the first one. Download and read the 6 Data Integrity 483s for free.

Subscribe to our monthly newsletter for regulatory and quality insights and developments.

4 of the 483s are available on the FDAzilla store:

  1. Raxbury, India, Jan 2014
  2. Hill Dermaceuticals Feb 2010
  3. Formulation Technology July 2013
  4. Zhejiang Hisun Pharmaceutical March 2015
Download the free whitepaper: 6 Data Integrity 483s.

 

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence. Contact me if you ever have questions at tony@fdazilla.com.



Subscribe to our monthly newsletter for regulatory and quality insights and developments.

One thought on “To Understand Data Integrity, Just Read These 6 FDA 483s

  1. Mihali

    This is really important since many clinical trials are going to India due to genetic heterogeneity of the population compared to China. Many agencies involved in this process are simply unaware and poorly trained in global regulations.

    Reply

Leave a Reply

Your email address will not be published. Required fields are marked *