How could this outbreak have been prevented? Which regulations were violated? What would be the three most important components of a quality system to prevent this type of contamination and resulting outbreak?

Meningitis outbreak

In this scenario, the FDA investigates a meningitis outbreak.

Situation: There is a potentially deadly outbreak of meningitis that may be linked to an injectable steroid medication.

Instructions: Navigate to the FDA website (Links to an external site.), for an overview of the meningitis outbreak (Links to an external site.). Then, from the Northwestern Library, find a minimum of two articles that discuss the details of this outbreak. Discuss the scenario, including:

• Who is responsible for this outbreak? Why?

• How could this outbreak have been prevented? Which regulations were violated?

• What would be the three most important components of a quality system to prevent this type of contamination and resulting outbreak?