ABSTRACT
The Food and Drug Administration (FDA) inspections, including pre-approval inspections, are to occur at a reasonable time, with reasonable limits, and in a reasonable manner. The division of the FDA reviewing the application may request a preapproval inspection of the sponsor’s manufacturing facilities and clinical trial sites. The FDA has a number of enforcement options if it believes that a manufacturing site is in noncompliance with the law. The FDA notes in its warning letters that failure to comply with the Federal Food, Drug, and Cosmetic Act and the FDA’s implementing regulations can lead to product approval delays. The results of the pre-approval inspection may affect the agency’s final approval decision. If a pre-approval inspection discovers significant good manufacturing practices problems or other issues, the reviewing division may withhold approval until the issues are addressed and corrected.
