THE FDA AND TurboEIR – HOW IT’S MANAGED AND MISMANAGED FORM FDA 483s

TurboEIR is a FDA software program designed to standardize Form FDA 483s and Establishment Inspection Reports (EIR).  It was completely “rolled out” in October 2002. For each “Objectionable Condition” (FDA 483 Observation), TurboEIR requests the inspection team to choose a “canned” citation and then describe the details of the situation.  In addition, each “canned” citation contains a paraphrase of the underlying authority. Quite often the underlying authority is a regulation from Title 21, Code of Federal Regulations, but may also be a statutory reference.
TurboEIR is strongly encouraged by FDA management for the purpose of writing accurate, consistent, and complete reports and documents as well as increase the efficiency of report writing.

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