An FDA warning letter often means a tipping point has been reached
Every week there is some news, recall or event that reminds us that the give and take with the FDA over manufacturing often means poor GMPs give companies major headaches and take a lot of time and money to resolve.
A week ago, it was Johnson & Johnson ($JNJ) recalling nearly 70,000 packages of its K-Y Liquibeads Vaginal Moisturizer. This week it is an item on how Extra Strength Excedrin will cost you up to $100 a bottle on eBay. Extra Strength Excedrin is one of Novartis' ($NVS) many OTC products that are in short supply since closing a plant in Lincoln, NE, for remediation.
The thing is, when companies get to the point of a warning letter from the FDA, problems often have reached a tipping point, a place that takes an incredible amount of resources to rebalance. The examples you will find in our 2012 FDA Red Flags Report are not all tipping point examples but many are.
The report serves as a kind of warning itself on why companies just don't want to get to the place where they are receiving FDA warning letters. I can't imagine there isn't a company in this report that doesn't wish now that it had taken a different tack along the way and spent the time and money earlier to steer a different course. Of course hindsight is always 20/20. Read and see what you think. Click here to view the full report >> -- Eric Palmer (email | Twitter)