Category Archives: Form FDA 483

FDAzilla’s Top 14 Posts of all Time

Over the years, the FDAzilla blog has published almost 300 articles. We’ve acquired a lot of new readers since we started writing here in 2010. With these newer followers in mind, FDAzilla has assembled a list of some of our most useful articles. To put together this collection, we considered which posts have been the most searched-for and viewed over time, and evaluated these popular posts for helpfulness and continued relevance.

We hope this compilation will serve as a resource for you and your company. It should also help orient you to the scope of the FDAzilla blog as you continue to follow our efforts to provide accessible FDA data and insights.  Continue reading

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. Continue reading

5 FEATURES TO LOOK FOR IN A WARNING LETTER

5 FEATURES TO LOOK FOR IN A WARNING LETTER

Warning letters are the FDA’s second level of enforcement actions after issuance of a form 483. The FDA determined that either the firm’s response to the form 483 was inadequate or the observations were serious enough to support issuance of a warning letter.   Often it is possible to determine the corrective actions necessary and the impact that the warning letter will have on the business.  To determine a letter’s impact on the business, I ask these questions:

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5 FEATURES TO LOOK FOR IN AN FDA FORM-483

 5 FEATURES TO LOOK FOR IN AN FDA FORM-483

A form-483 is the document that FDA issues at the close of an inspection where they identify observations made during the inspection.  If no observations have been made, no form 483 is issued. Based on the response submitted by the firm, FDA classifies the inspection as:  No Action Indicated (NAI) when no form 483 is issued, Voluntary Action Indicated (VAI) or Official Action Indicated (OAI).  In general, where FDA issues a form-483 with observations and the firm’s response is satisfactory, the inspection is classified VAI.

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