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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"
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