Skip page top navigationFDA Logo--links to FDA home page Logo of and Link to start page of Office of Regulatory Affairs, U.S. Food and Drug Administration HHS Logo and link to Department of Health and Human Services website

FDA Home Page | Compliance Ref | Federal-State | Inspection Ref | Import Program | Science Ref | ORA Search


Inspection References
Investigations Operations Manual 2004
Previous Page | Document TOC | Next Page


Foreword 2004

The Investigations Operations Manual (IOM) is the primary source of guidance 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. Since the IOM is the primary source of policy, the specific information in this manual is supplemented, not superseded, by other manuals and field guidance documents.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.

In its role of protecting the public health, ORA developed a vision, a mission statement and specific core values. These are depicted in the pages immediately following this "Foreword".

There are many changes and additions to the Year 2004 IOM. Chapter 4 includes revisions to the sample schedule charts 3, 4, and 15. We have updated the Import for Exports instructions in 501.07 and 602 to reflect changes initiated by the Bioterrorism Act of 2002. Chapter 5 includes many updates: section 512 Reports of Observations and 590 inspection report writing. A Personal Safety section was added to enhance awareness of workplace safety issues. A new section on Food and Cosmetic reconciliation examinations was added; these activities will be performed during routine food and cosmetics inspections and import examinations / entry reviews. A new section on Food registration requirements and inspection guidance was also added. Chapter 9 now includes guidance on Counterfeit product investigations in the Tampering section. Please take time to review sections of the IOM that apply to your work.

Since December 1996, the IOM has been posted to ORA's Internet Home Page, http://www.fda.gov/ora/inspect_ref/iom/iomtc.html. The entire IOM is available there, with all graphics included. Future updates to the IOM will be done periodically during the year to this on-line version. Hard copy publication will be done yearly. 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 2005 edition of the IOM or recommended changes, deletions, editions for updates to the IOM may be sent to the Division of Field Investigations (HFC-130), 5600 Fishers Lane, Rockville, MD 20857 or via e-mail to Director, DFI. You can also send e-mail for the IOM to IOM@ORA.FDA.GOV. If you are recommending a change or revision, please use the IOM Change Request Form available from the web site and included in the IOM as Appendix H.

John M.Taylor, III, 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).

 

Page Top Previous Page | Document TOC | Next Page