Regulatory: FDA Warning Letter Top Citations

Looking at the past 3 years of warning letters we can count the number of letters that cite a specific regulation at least once. In this way we can see which part are cited in most letters by FDA and therefore the area in whioch companies most commonly fail.

As we can see, there are three areas that really stand out for continual citation;

• 820.100 Corrective and preventive action...
• 820.198 Complaint files....
• 820.30 Design controls....

It is clear that the first two are co-dependant, and a failure in managing design controls will also feed into Complaints and CAPA.

Drilling down into the detail, we can see in individual warning letters that time and again, companies do not manage complaints correctly. Key failures include:

• Not assessing complaints at all,
• Dismissing complaints as not critical or not investigating fully (no risk assessment or justification),
• Not implementing corrective actions,
• Not describing preventative actions or managing risk from failures,
• Lacking procedures,
• Having procedures but not following the processes.

So the key message is treat complaints seriously, and if you do decide they do not require CAPA, make sure there is a documented rationale including risk analysis for that decision.