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Some regulatory inspectors interpret response as an action finding and not a simple acknowledgement of receipt. Are we seeing a trend in one direction?

29 Oct

Webinar - Complaint Handling - Best Practices

Answered by - David Lim


We have to consider 360 degree views in whatever we do, for example one simple response could be used against the Company at some point. Whatever information we provide to patient or other Companies, we have to interpret it in a way that this could possibly lead to a future litigation against the Company. So, I think these days many Companies are becoming very cautious regarding complaints from patients and other competitors, so they try to minimize what they share with the public, therefore I think a Simple acknowledgement receipt is getting major trend.

Due Diligence Complaint Handling acknowledgement receipt Fda inspection regulatory FDA Quality Manufacturing
What is the standard for Due Diligence attempts to procure samples responses from unresponsive Complainant?
We are a drug manufacturer, in your experience what is the percentage of companies whose response to the customer consists of a simple response to the customer versus a response which include a finding and a corrective action?
Definition of Day zero or consideration of Day Zero in cases where the Company uses third party call center to perform intake of complaints from the open channel for a toll free number, fax, Web email
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