FDA INSPECTION

FDA inspect establishments that manufacture, process or pack FDA regulated products like medical device, drug, cosmetic, food etc. FDA conduct random inspection with short notice to verify the GMP compliance. FDA ORA (office of Regulatory Affairs) is responsible for field inspections... After inspection if any non-conformities (non-compliance) found, FDA will issue an Establishment Inspection Report (EIR) with observations listed on form FDA 483.

Also known as: FDA

Primary location: Aurora United States