The complain that Quality is a burden must come from people that do not understand the history of manufacturing mistakes that resulted in products that put people’s lives at risk and intricacy processes of ensuring quality of the product. I worked for a company that was under consent decree and lack of quality assurance was one of the issues that the company had which led to this agreement with FDA. As part of settlement the company agreed pay $500 million on products produced during the three years prior to the signing of the consent decree and pay $175 million in future profits if it failed to adhere to the timelines established in the decree. Additionally, FDA withheld approval of the company’s products, company shares fell 15 percent in a day, and investors filed a $165-million class action suit. As mentioned during the lecture, inadequate QA/QC can lead to devastating consequences and will put companies out of business. Fortunately, the company was a large corporation and had financial means to turnaround and get out of the consent decree.