According to its Foreword, the Investigations Operations Manual (IOM) is the primary operational guide for FDA employees who perform field investigational activities in support of the agency's public health mission. As defined in the IOM, “An establishment inspection is a careful, critical, official examination of a facility to determine its compliance with certain laws and regulations administered by FDA.”
If, during an establishment inspection, an investigator identifies what (in his or her judgment) are believed to be objectionable conditions, these conditions will be communicated to the organization during the inspection and at the conclusion of the inspection via discussions and issuance of an FDA 483 List of Inspectional Observations.2 The FDA 483 observations are, in the investigator’s judgment, potential violations of a regulatory or statutory requirement, as discussed in Section 5.2.3 of the IOM3. The investigator’s observations will also be documented within the Establishment Inspection Report (EIR) representing the inspection for review by FDA management and potentially an FDA compliance officer. FDA investigators will not typically advise a manufacturer with respect to corrections and corrective actions relative to FDA 483 observations raised during an establishment inspection.
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