There is no doubt that Hospira should get a Consent Decree. However,the FDA has two sets of rules. One for big Pharma and one for generic manufacturers. They will give Hospira the benefit of the doubt so that low cost Medicines will remain available and not cause more drug shortages as a result of the extra red tape required to release product due to a consent decree. Hospira needs a new culture that embraces Quality and compliance starting at the top.
Project fuel was lime pouring gasoline on an open fire.