FDA Basics for Industry

What should I expect during an inspection?

 

FDA may conduct an inspection of your operation for a variety of reasons, such as a routinely scheduled investigation, a survey, or a response to a reported problem.

 

More  

I want to manufacture an FDA-regulated product. Where do I start?

 

Start by visiting the FDA web pages dedicated to that commodity. You will find valuable guidance there. The guidance quotes the law and regulations applicable. You can look up the laws...

 

More  

 

Additional Resources

• What We Do
• What does FDA regulate?
• FDA Performance Data
• FDA's Remote Oversight Tools (includes the Remote Regulatory Assessments (RRA))