Under the Federal Food, Drug and Cosmetic Act, SEC. 704 (21 USC §374) “Factory Inspection” the United States Food and Drug Administration (FDA) is authorized to perform inspections of US and foreign facilities. Form FDA 483 (Inspection Observations) is used by FDA to document concerns discovered during inspections.
The 483 states that it “lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional [...] Read More