This three-part series will discuss how to respond to the U.S. Food and Drug Administration’s Form 483 (FDA 483), which is issued at the conclusion of an inspection to document potential violations to the Federal Food, Drug, and Cosmetic Act. We’ll look at how to assess the work needed to address the possible violations in a sustainable way, and how to establish a method to guide the remediation work.

Although not legally required, it’s standard industry practice to respond to FDA 483 observations. Companies that want to be responsive and have a good relationship with the FDA respond to each observation by describing exactly how problems will be addressed.

There’s plenty of advice available, even from the FDA, on what constitutes a good response. For certain, the difference between a good and a poor response may calibrate how you are viewed by the FDA.

From my experience, the following are points to consider that have worked well when forming a response:

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