FDA Regulations Documents
FDA Regulations
NDC Labeler Code and Establishment Registration Guide
This document provides essential instructions for generating NDC Labeler Code and Establishment Registration SPL files. It focuses on leveraging FDA's free tools while also mentioning options from vendors for various user needs. Users will find vital resources for submitting SPL files effectively within this guide.
FDA Regulations
Understanding the Form FDA 483 Process and Timeline
This file presents essential information about the FDA 483 process and its timeline. It is useful for regulatory affairs professionals and companies engaging with the FDA. The guide offers insights into inspection observations and compliance requirements.