FDA Inspection
FDA inspection is done primarily to determine if the inspected company/process complies with FDA guidelines and meets the terms of Federal Food, Drug, and Cosmetic Act (FDCA).
Significantly, other than the businesses that manufacture FDA-regulated products, clinical trial sites and nonclinical laboratories conducting plant, animal or microorganism studies used in FDA applications for drugs, biologics, or devices come directly under the purview of FDA and hence, can be inspected.
There are 2 basic types of FDA inspections: Surveillance inspection – is routine FDA inspection, whereas the Compliance Inspection is based on specific objective, such as compliant or other suspected specific problem like unreported Adverse Events (AEs).
