On August 11, 2009, the FDA published a notice announcing a program to establish a deadline for inspected establishments to submit post-inspection responses to FDA 483 inspectional observations for the FDA’s consideration in deciding whether to issue warning letters. According to the FDA, delayed and multiple responses to an FDA 483 have resulted in delays in the issuance of warning letters while these responses are reviewed and addressed. Under the program, the agency will not ordinarily delay the issuance of a warning letter in order to review a response to an FDA 483 that is received more than 15 business days after the FDA 483 was issued. The purpose of this program is to optimize resource utilization, facilitate the timely issuance of warning letters, and promote prompt correction of violations. FDA will assess the program after approximately 18 months to determine whether to make it permanent. The program will begin on September 15, 2009.