You Just Got An FDA Warning Letter – What Should You Do Next?

By Ed Miseta, Chief Editor, Clinical Leader

You took your time selecting a CMO partner. You prepared a quality agreement specifying each company’s responsibilities, and you did your best to monitor the quality of the product they produced. But somehow you still managed to receive a FDA-483 (Notice of Inspectional Observations) or a warning letter. What do you do now?

Attorney Alan Minsk, partner and leader of the Food and Drug Practice for law firm Arnall Golden Gregory LLP, believes your response is critical to satisfying the concerns of the FDA — and putting the situation behind you as quickly as possible. The timing of your response is the first issue you must consider.

“When the FDA issues a warning letter, it expects an answer within 15 days,” says Minsk. “That is the understood rule. If you don’t respond within 15 days, it can be perceived as though the company doesn’t consider the matter serious, which can lead to more significant enforcement.” You don’t want haste to make waste, he warns, but remember this is a government agency, and you do not want to thumb your nose at them. At the same time, he cautions responders to not feel as if they need to respond the next day. The goal should be to put together a thorough and efficient response in a timely manner.