Warning Letters Galore: Causes And Prevention

With Warning Letters and other regulatory action hitting an all time high let's take time to reflect and ask "What can we learn from the mistakes of others?"

In preparation for this article I canvassed the opinion of some learned friends and colleagues within NSF-DBA and, importantly, some senior managers still at the industry coal face. This illustrious group have over 260 years' combined pharma experience, and the scars to prove it. Some have been on the end of Warning Letters and other severe regulatory action, all keen to share their experience. As one of them put it "The moment that letter arrives nothing gets quicker, easier or cheaper. Nothing".

Although the 10 ‘Causal Factors' is not an exhaustive list, your probability of severe regulatory action will be greatly reduced if you give serious consideration to the ‘Learning Points'.

So, with their collective minds focused on causes and prevention, this is what they had to say!