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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Foreword 2013

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 health 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 The specific information in this manual is supplemented, not superseded, by other manuals and field guidance documents.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.

For 2013, the IOM contains some important changes which clarify or present new information and procedures.  Of particular note is the reorganization of ORA headquarters which is highlighted in Subchapter 1.9.  Other noteworthy changes include revision to the records access section in Chapter 5, to reflect the new authorities provided by the Food Safety and Modernization Act (FSMA). In addition, Chapter 5 has been updated to clarify the legal sanctions available to FDA for violations of the Food, Drug and Cosmetic Act, and the end date of inspections.

As with each new edition of the IOM, please take time to review sections of the manual for changes which may apply to your work.

Since December 1996, the IOM has been posted on ORA's Internet Website, http://www.fda.gov/ora/inspect_ref/iom. The entire IOM is available there, with all graphics included. Future updates to the IOM will be performed periodically during the year to the on-line version. The hard copy is published annually. Remember, whether reviewing the "hard copy" or the "on-line' version of the IOM, the most recent version is the document of record.

We are committed to the continual improvement of the quality and usefulness of the IOM. Suggestions for the 2014 edition of the IOM or recommended changes, deletions, additions to the IOM may be sent to the Office of Operations, 12420 Parklawn Drive, Rockville, MD 20857 or via e-mail to IOM@FDA.HHS.GOV. If you are recommending a change or revision, please use the IOM Change Request Form available from the FDA web site.

Thank you for your continued hard work and dedication in protecting and promoting the health and well-being of the American people.



Melinda K. Plaisier, Acting Associate Commissioner for Regulatory Affairs
FDA/Office of Regulatory Affairs

NOTE: This manual is reference material for investigators and other FDA personnel. The document does not bind FDA and does not confer any rights, privileges, benefits or immunities for or on any person(s).