FDA 483 Warning Letters are becoming quite frequent for pharmaceutical manufacturers, and the consequences can be dire in the worst case. Unfortunately, the “right way” to respond is complicated. For sure, there are legions of experts and consulting firms, who can be very valuable. But at the end of the day, after all the consultants and lawyers have had a go at the response, it is critical to ask if the company and the FDA are on the same planet in terms of communicating. Frequently not.
http://lnkd.in/D4Z2TF
linkedin post 2022-06-29 05:12:48
Nigel Fleming
September 21, 2022