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Peer Review: Why You Need It; How You Get It Steven Courtney, PhD RESOLVE Director of Collaborative Science 1 November 15, 2012 2 Collaborative Science The nexus of policy, science, and the public
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Form 483 - Sunland is a form issued by the U.S. Food and Drug Administration (FDA) to notify a company about violations observed during an inspection of their facility.
Any company or facility that is inspected by the FDA and found to have violations may be required to file Form 483 - Sunland.
Form 483 - Sunland can only be filled out by the FDA. The FDA compiles the form based on their observations during the inspection.
The purpose of Form 483 - Sunland is to notify a company or facility about violations observed during an FDA inspection and to request a response or corrective action plan.
Form 483 - Sunland reports violations observed during an FDA inspection, including the nature of the violation, the specific regulations that were violated, and any recommended corrective actions.
The deadline to file Form 483 - Sunland in 2023 may vary depending on the specific inspection date and FDA requirements. It is best to consult the FDA or legal counsel for accurate deadline information.
There is no specific penalty mentioned for the late filing of Form 483 - Sunland. However, delays in addressing violations or not responding to the form may result in further regulatory action or consequences for the company or facility.
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