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.
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fda_public
created
Sun, 24 Jun 2012 14:26:20 GMT
creator
dirkjan
modified
Sun, 24 Jun 2012 14:26:20 GMT
modifier
dirkjan
tags
FDA
Term
creator
dirkjan