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Regulatory
What is Form 483?
FDA Form 483 Inspectional Observations
Definition
An FDA Form 483 is issued by an investigator at the end of an inspection to list observed conditions that may violate the Food, Drug, and Cosmetic Act. It is a list of observations, not a final determination of non-compliance.
Industry Context
PharmaTek links Form 483 observations to company profiles so buyers can spot patterns when qualifying a supplier.