Title: Learning Community: Enforcement Actions
Course: PW-Course-Import-Test > Section: Module 1: Introduction to Medical Device Quality Systems

Review the list of enforcement actions for 2015 on the FDA website. After navigating to the website via the link, select “Devices” from among the available categories.

Write a summary for one (1) enforcement action from your own experience or select an example from the FDA website for 2015. Include the following considerations in your summary:

1. What section of 21 CFR 820 is your selected enforcement action related to?
2. Based on the information available to you, what was the likely cause of the citation/infraction?
3. What action(s) or steps are required to correct the citation/infraction?

Post your answers below.