Establishment Inspection Report

The Establishment Inspection Report (EIR) is the report completed by the FDA investigatprs after an inspection os completed an forwarded to their district office. The report is lengthy an provides details of the form, its management, products, the inspection, the investigators findings and concerns related to the 'objectionable conditions or practices that are identified in FDA 483 as 'observations'.

During delivery of the FDA 483 form whenever the inspector makes a 483 observation that you believe may not be correct, you should note your position politely but firmly and request it be noted in the EIR.