On March 31 of this year, the FDA recalled Mylan’s EpiPen and EpiPen Jr Autoinjector products used for emergency treatment of severe allergic reactions. The product is recalled because of a defective part that could result in the device’s failure to activate.
In week 10’s lecture we learned about the closing phase, where the project design controls are finally finished and the project team hands off the device to development to production. Thus, the team is getting ready to create documents that manufacturing needs.
Thus, Mylan’s recall on EpiPen can result either in manufacturing or during the design controls.
Name some areas in this long process of project development, where something went wrong when developing the EpiPen product. What management steps would the project manager take to solve this issue? (Nothing technically)/
What phase in the management process will project in because of the recall? Why?

Reference: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm550170.htm