Phil Cuscuna

The Key to Preventing FDA Warning Letters and 483 Observations Phil Cuscuna

You just received a phone call telling you that the US FDA will be coming to INSPECT your medical device company! Or perhaps it's been a few years and you are anxiously expecting them to show up on your door step. DON'T PANIC! Finally, there is a book that guides you step by step, in easy to understand language, that guides you in preparing. Whether you are a well prepared large multi-billion dollar enterprise or a small unprepared "mom and pop shop", this guide is for you. This book will replace the anxiety and nervousness you feel and replace it with confidence. Written by a seasoned pro with 30 years of experience and hundreds of inspections and audits you will emerge with a solid attack plan.