Post-Inspection Response Documents

Receiving a form 483 is a normal outcome of an FDA regulatory inspection. Your post-inspection response is evaluated by the FDA, and the degree to which your company addresses major concerns raised by the FDA investigator determines how they will classify your CGMP status.

Our consultants offer assistance in formulating an appropriate response, or reviewing your proposed 483 response, and drafting precisely worded language that addresses FDA concerns. Our stated goal is to help you achieve and maintain an acceptable compliance status with the FDA.