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FDA Basics for Industry

What should I expect during an inspection?

Inspectors at the grocery store
 
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.
 
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I want to manufacture an FDA-regulated product. Where do I start?

man in suit holding a pen
 
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...
 
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