If you’re a medical device company manufacturing Class II or Class III devices, you can expect to have the U.S. Food and Drug Administration (FDA) turning up for an inspection. It’s what happens after that inspection that we’re concerned with in this article.

The unfortunate truth of the matter is that some of you will receive Form 483 observations, and some will then receive warning letters. It’s important that you understand the differences between the two, as well as what will be expected of you in either case.

What is an FDA 483 observation?

An FDA Form 483 observation, or “inspectional observation,” is a notice sent by the FDA to highlight any potential regulatory violations found during a routine inspection. This can relate to the company’s facility, equipment, processes, controls, products, employee practices, or records.

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