Case Management and Guidance
FDA field office investigators conduct inspections of manufacturing facilities. If it appears that a warning letter or other regulatory action is indicated, a copy of the report (FDA-483) is sent to the FDA district compliance branch. Section 704(b) of the Federal Food, Drug and Cosmetic Act (FD&C Act) specifies that upon the completion of an inspection and prior to leaving the premises, FDA shall give a written report of objectionable conditions to the owner, operator or agent in charge. If significant deviations are found after reviewing the report, the district compliance branch makes a recommendation of follow-up action. The Agency can choose to warn the manufacturer by way of a warning letter, untitled letter or an injunction for closure. If field office investigators encounter any issues they can call the case management team for guidance and direction. Field recommendations are sent to OC's case management team for review of merit. The team reviews the inspection report findings, determines the appropriate regulatory action, and then drafts a decision memo.