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design controls | Medical Device | Compass

Mitigate the Risk of an FDA Form 483 with an Automated Solution

By: Cognition Corporation
July 27th, 2020

Commonly issued after an FDA inspection, a Form 483 informs a company of observations requiring corrective actions. The Form 483 is often referred to as “Inspectional Observations” as it is a list of conditions or practices that indicate a potential violation of FDA requirements. The form is compiled in order of importance and is considered a snapshot of potential issues; it should not be considered all-encompassing.

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