FDA Warning Letter calls explicitly for CAPA

Recommendation

7/8 May 2024

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Again, the U.S. Food and Drug Administration FDA has issued a Warning Letter mainly focussing on Data Integrity.

This new Warning Letter contains GMP observations in four areas:

• Incomplete data in laboratory records;
• Inappropriate controls over computer systems;
• Inadequate written procedures for production and process controls;
• Failure to follow certain written procedures.

In the description of the observations data integrity deficiencies become obvious which are circumstantiated in a detailed way.

But what is interesting with this one is that FDA clearly proposes some necessary actions and asks for appropriate corrective and preventive actions (CAPA). This description of the corrective actions seems unusual but appears to be part of a trend in Warning Letters:

• A "comprehensive investigation into the extent of the inaccuracies in data records and reporting", including "interviews of current and former employees … by a qualified third party;"
• A "current risk assessment of the potential effects of the observed failures on the quality of your drugs," including the risk to patients;
• A "management strategy for your firm that includes the details of your global corrective action and preventive action plan," including "measures describing the actions you have taken or will take to protect patients and to ensure the quality of your drugs, such as notifying your customers, recalling product, conducting additional testing, … drug application actions, and enhanced complaint monitoring."

A reason for this might be that FDA is concerned with the company's first response. The proposed actions of the company were "insufficient to correct the broad data manipulation and deletion problems observed at your facility and to prevent their recurrence." FDA also asks that in the response "an assessment of the effectiveness of these newly implemented system controls" should have been provided.