Resources for Food and Drug Administration (FDA)

FDA Office of Regulatory Affairs: Investigations Operations Manual (IOM) 2006

US Food and Drug Administration, Office of Regulatory Affairs

The Investigations Operations Manual (IOM) is the primary source regarding Agency policy and procedures for field investigators and inspectors. This extends to all individuals who perform field investigational activities in support of the Agency's public mission. Accordingly, it directs the conduct of all fundamental field investigational activities. Adherence to this manual is paramount to assure quality, consistency, and efficiency in field operations. The specific information in this manual is supplemented, not superseded, by other manuals and field guidance documents. Recognizing that this manual may not cover all situations or variables arising from field operations, any significant departures from IOM established procedures should have the concurrence of district management.

2006 brings a new IOM with many changes. The IOM was significantly revised by incorporating a new numbering system, reorganizing content, expanding the index, and making the IOM more user friendly. Over the years, the addition of new content outgrew the IOM's numbering system. The IOM was renumbered in a format utilized by International Standards organizations. Content was reorganized into shorter, more readable sections, improving searchability.

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