What’s the Best Way to Address 483s Related to Design Controls?

Bolstering Compliance Through Proactive and COrrective Approaches is Important

Importance_of_483s_LPImageIn FY2017, FDA inspectors tallied up over 1,000 inspectional observations for medical device organizations. Of those observations, over 400 alone related to design controls—very nearly half of all documented citations. What does that mean for your organization?

In our latest eBook, “FDA Form 483s and Design Controls: The Importance of Managing and Mitigating Inspectional Observations Related to Design Controls,” we dive into the basics of 483s and how they can impact your organization when related to design controls. As well, the paper explores what recent data says about the most commonly cited design controls observations and ways to address them from a holistic perspective.

Download the eBook today and learn more about:

  • Reasons why design changes may be high priority for inspectors
  • The impact of 483s related to design controls on time and resources
  • How robust risk management can mitigate observations

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