“Firms need to do their homework. We have entered a new era of FDA enforcement. They have made it quite clear that they are going deeper now. They are not just going to check to see if you have a procedure to identify incoming raw materials, they are going to look at it those procedures are valid. They are going to look at claims substantiations. They are going to look a NDI notifications if you need them,” said Wasserman, who is a partner in the firm Manatt, Phelps & Phillips.
“I know it’s self serving, but it is incredibly frustrating as a lawyer who wants to help companies to get the call when FDA is in their plant or when the warning letter has arrived,” he said.
“It’s easily three or four times as expensive to go into FDA to negotiate a settlement. At that point you are not just talking about legal fees, but you may be talking about product recalls. The most recent warning letter resulted in a massive recall and millions of dollars of product being destroyed,” he said.