What USFDA 483s and should be aware about currently issued 483s?

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Accepted Answer

USFDA 483s are inspection observations issued by the FDA to a company detailing any violations found during inspections.

USFDA 483s are issued to companies after inspections to notify them of any violations found during the inspection.
Companies are required to respond to the 483s with a corrective action plan to address the violations.
Failure to address the violations in a timely manner can lead to further regulatory action by the FDA.
Examples of common violations found in 483s include inadequate record keeping, failure to follow established procedures, and lack of employee training.
It is important for quality assurance team leads to stay informed about current 483s to ensure compliance with FDA regulations.

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