Warning Letter Response
A Warning Letter has a profound impact on your business and business reputation. A Warning Letter is, in effect, just a continuation of the communication between the FDA and the company concerning your 483 response.
The Warning Letter will explain what has been accepted from your 483 response and what observation(s) were not appropriately addressed. Like the 483 response, a Warning Letter response must be comprehensive and address every aspect of the Quality System impacted by the correction.