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17 Aug 2016

What is difference between Form 483 and Establishment Investigation Report ?

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The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, Sec. 704 (21 USC §374) “Factory Inspection”. Both terminology related to that.
Let understand the differences between the two terminology.
  • Form 483
    Form 483 is used by the investigator conducting the investigation (FDA investigator) in order to document his findings. It is delivered directly at the end of the inspection and should be answered officially. The answer is expected within 15 working days after issuing Form 483. This is the only way to ensure that the response is taken into account when a warning letter (see below) is issued. However not in every inspection a Form 483 is issued.

  • EIR: Establishment Investigation Report
    The EIR is issued by the investigator in addition to Form 483. This should be done within 30 working days. The EIR will then be reviewed by the competent FDA centre.  The following statuses are assigned:
    NAI: No Action Indicated – there were no objectionable conditions found during the inspection.
    VAI: Voluntary Action Indicated – there were objectionable conditions found but the authorities do not need to take any measures. All measures (CAPAs) by the company are taken on a voluntary basis.
    OAI: Official Action Indicated – there were objectionable conditions found and further regulatory action is initiated (such as a Warning Letter).
    The EIR is made available to the inspected company, but it can also be requested by other companies under the so-called “Freedom of Information Act”. Experience has shown however that it can take quite a long time until an external EIR is transferred.

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