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.
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.
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4 of the 483s are available on the FDAzilla store:
- Raxbury, India, Jan 2014
- Hill Dermaceuticals Feb 2010
- Formulation Technology July 2013
- Zhejiang Hisun Pharmaceutical March 2015