Skip to main content

Download Form

FDA Close-Out Letter Sample

Description: The FDA has the power to conduct regular inspections of regulated entities. They report the findings of their investigations on Form 483 and may issue a warning letter, which gives the company a chance to correct any violations found. If the violations are promptly corrected the FDA will issue a close-out letter indicating that the company is in compliance, subject to further inspections. This form provides a sample close-out letter.
Form Type: Letters
Practice Area: Health Care

Date: Jun 2014
PLI Item #: 58704
Keywords: pharmaceuticals; "compliance and enforcement"; FDA; "Food and Drug Administration"; FFDCA; "Federal Food, Drug and Cosmetic Act"; "form 482"; "form 483"; "warning letter"; "close-out letter"; "untitled letter"
Thank you for exploring PLI PLUS.
The content on this page is only available to subscribers.

To learn more about PLI PLUS subscriptions
please click on the link below or contact us at