When FDA takes an action such as sending a warning letter to a company or takes an enforcement action, is the shortage impact considered beforehand?

FDA is responsible for ensuring that safe, effective drugs are available for US patients. When there are severe quality issues identified that could result in harm to patients, there may not be a way to avoid a shortage. However, FDA does everything possible to work with firms to address any potential risks to keep medically necessary products available while also ensuring there is not going to be harm to patients associated with the quality issues.