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FDA Close-Out Letter Sample
Pharmaceutical Compliance and Enforcement Answer Book (2020 Edition)
Book Publication Date:
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.
PLI Item #:
"compliance and enforcement"
"Food and Drug Administration"
"Federal Food, Drug and Cosmetic Act"
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