On Aug. 6 2009, the new FDA Commissioner, Dr. Margaret Hamburg, outlined the FDA’s new postinspection deadline and warning letter process. According to Dr. Hamburg, when the FDA finds that a firm is significantly out of compliance the FDA will expect a prompt response to its findings. Once the FDA provides inspection findings identifying a serious problem, the firm will generally have no more than 15 working days in which to respond before the FDA moves ahead with a warning letter or enforcement action. This will help FDA issue warning letters on a timely basis and facilitate prompt corrective action. The FDA will be prepared to act swiftly and aggressively to protect the public. The FDA will no longer issue multiple warning letters to noncompliant firms before taking enforcement action. If the FDA finds that it must move quickly to address significant health concerns or egregious violations, it will consider immediate action – even before it issues a formal warning letter. This new process is scheduled to begin on Sept. 15, 2009 and will be re-evaluated after 18 months.