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Common Reasons for FDA 483 Inspectional Observations in Biologics Manufacturing Environments
An FDA 483 is the name of a form used by the FDA during the inspection and audit of a regulated facility. The form is used to describe an auditor's observations and does not represent official association findings. These observations are often referred to as 483 observations or 483s by all industries regulated by the FDA. 483 observations that are not addressed within a stipulated time period or that are identified as major safety issues may constitute violations and can result in a warning letter(s).
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