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Investigations Operations Manual
Foreword
Ch 1 Administration
Ch 2 Regulatory
Ch 3 Federal-State Cooperation
Ch 4 Sampling
Sample Schedules
Ch 5 Establishment Inspection
Ch 6 Imports
Ch 7 Recall Activities
Ch 8 Investigations
Exhibits
Appendix
ORA Directory
Change Log
Search
Inspection References
Investigations Operations Manual 2008
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Chapter TOC
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Contents
3.1 - COOPERATIVE EFFORTS
3.1.1 - POLICY
3.1.2 - LAWS, CODES, AGENCIES
3.1.2.1 - Agreements and Memoranda of Understanding (MOU)
3.1.3 - OTHER GOVERNMENT INSPECTION
3.1.3.1 - Federal
3.1.3.2 - Discussion with Federal Inspector
3.1.3.3 - State and Local
3.2 - FEDERAL AGENCY INTERACTION
3.2.1 - U. S. DEPARTMENT OF AGRICULTURE (USDA)
3.2.1.1 - Foods Rejected by USDA
3.2.1.2 - USDA Complaints
3.2.1.3 - USDA Acts
3.2.1.4 - FDA-USDA Agreements & MOUs
3.2.1.5 - Agricultural Marketing Service (AMS)/USDA (MOU's)
3.2.1.6 - Animal Plant Health Inspection Service/USDA (APHIS)
3.2.1.7 - Federal Grain Inspection Service/USDA (FGIS)
3.2.1.8 - Food Safety and Inspection Service/USDA (FSIS)
3.2.1.9 - Science and Education Administration/USDA (SEA)
3.2.2 - U.S. DEPARTMENT OF COMMERCE (DOC)
3.2.2.1 - Commerce (DOC)
3.2.2.2 - National Oceanic and Atmospheric Administration (NOAA) - National Marine Fisheries Service (NMFS)
3.2.2.3 - U.S. Patent and Trademark Office (USP&TO)(DOC)
3.2.3 - DEPARTMENT OF DEFENSE (DOD)
3.2.3.1 - DOD MOU's
3.2.3.2 - US Army Corps of Engineers (DOD)
3.2.3.3 - US Army Medical Research and Development Command (DOD)
3.2.3.4 - Defense Personnel Support Center (DPSC)
3.2.3.5 - Department of Navy/Bureau of Medicine and Surgery
3.2.4 - DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
3.2.4.1 - HHS MOU's
3.2.4.2 - Administration for Children, Youth and Families (ACYF)
3.2.4.3 - Centers for Disease Control and Prevention (CDC)
3.2.4.3.1 - Interviews
3.2.4.3.2 - Information Exchange and Coordination
3.2.4.3.3 - Routine Requests for Information
3.2.4.3.4 - Emergency Requests for Confidential Information
3.2.4.3.5 - Liaison Officers
3.2.4.4 - Centers for Medicare and Medicaid Services (CMS)
3.2.4.5 - Health Services Administration (HSA)
3.2.4.6 - National Center for Health Statistics (NCHS)
3.2.4.7 - National Institute of Drug Abuse (NIDA)
3.2.4.8 - National Institutes of Health (NIH)
3.2.5 - DEPARTMENT OF HOMELAND SECURITY
3.2.5.1 - U.S. Customs and Border Protection
3.2.5.2 - Secret Service
3.2.5.2.1 - Liaison
3.2.5.2.2 - Definitions
3.2.5.2.3 - Purpose
3.2.5.2.4 - Criteria For Requesting FDA Assistance
3.2.5.2.5 - Scope of Investigation
3.2.5.2.6 - Interagency Cooperation
3.2.5.2.7 - District Contact
3.2.5.2.8 - Lead Investigator Qualifications
3.2.5.2.9 - Steps for Conducting a Special Secret Service Investigation
3.2.5.2.10 - Sampling
3.2.5.2.11 - Reporting
3.2.6 - DEPARTMENT OF JUSTICE
3.2.6.1 - U.S. Attorney
3.2.6.2 - Drug Enforcement Administration (DEA) (Formerly: Bureau of Narcotics)
3.2.6.3 - Federal Bureau of Investigation (FBI)
3.2.7 - DEPARTMENT OF LABOR: OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA)
3.2.8 - TREASURY DEPARTMENT
3.2.8.1 - Alcohol and Tobacco Tax and Trade Bureau (TTB)
3.2.8.2 - Internal Revenue Service (IRS)
3.2.9 - DEPARTMENT OF VETERANS AFFAIRS VETERANS ADMINISTRATION (VA)
3.2.10 - CONSUMER PRODUCT SAFETY COMMISSION (CPSC)
3.2.11 - ENVIRONMENTAL PROTECTION AGENCY (EPA)
3.2.11.1 - EPA MOU's
3.2.12 - AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY (ATSDR)
3.2.13 - FEDERAL TRADE COMMISSION (FTC)
3.2.14 - U.S. NUCLEAR REGULATORY COMMISSION (NRC)
3.2.15 - U.S. POSTAL SERVICE (USPS)
3.2.15.1 - Change of Address Information
3.2.15.2 - Postal Box Information
3.2.15.3 - Authority
3.2.16 - FIRM LOCATIONS
3.2.17 - FEDERAL FOOD SAFETY COALITION
3.3 - STATE OPERATIONAL AUTHORITY
3.3.1 - STATE OPERATIONAL AUTHORITY
3.3.1.1 - FDA Personnel with State Authority
3.3.1.2 - Joint Inspections
3.3.1.3 - FDA Commissioned State Personnel
3.3.2 - STATE MEMORANDA OF UNDERSTANDING
3.3.3 - STATE AUTHORITIES AND PHONE CONTACT NUMBERS
3.3.3.1 - Alabama (AL)
3.3.3.2 - Alaska (AK)
3.3.3.3 - Arizona (AZ)
3.3.3.4 - Arkansas (AR)
3.3.3.5 - California (CA)
3.3.3.6 - Colorado (CO)
3.3.3.7 - Connecticut (CT)
3.3.3.8 - Delaware (DE)
3.3.3.9 - Florida (FL)
3.3.3.10 - Georgia (GA)
3.3.3.11 - Hawaii (HI)
3.3.3.12 - Idaho (ID)
3.3.3.13 - Illinois (IL)
3.3.3.14 - Indiana (IN)
3.3.3.15 - Iowa (IA)
3.3.3.16 - Kansas (KS)
3.3.3.17 - Kentucky (KY)
3.3.3.18 - Louisiana (LA)
3.3.3.19 - Maine (ME)
3.3.3.20 - Maryland (MD)
3.3.3.21 - Massachusetts (MA)
3.3.3.22 - Michigan (MI)
3.3.3.23 - Minnesota (MN)
3.3.3.24 - Mississippi (MS)
3.3.3.25 - Missouri (MO)
3.3.3.26 - Montana (MT)
3.3.3.27 - Nebraska (NE)
3.3.3.28 - Nevada (NV)
3.3.3.29 - New Hampshire (NH)
3.3.3.30 - New Jersey (NJ)
3.3.3.31 - New Mexico (NM)
3.3.3.32 - New York (NY)
3.3.3.33 - North Carolina (NC)
3.3.3.34 - North Dakota (ND)
3.3.3.35 - Ohio (OH)
3.3.3.36 - Oklahoma (OK)
3.3.3.37 - Oregon (OR)
3.3.3.38 - Pennsylvania (PA)
3.3.3.39 - Rhode Island (RI)
3.3.3.40 - South Carolina (SC)
3.3.3.41 - South Dakota (SD)
3.3.3.42 - Tennessee (TN)
3.3.3.43 - Texas (TX)
3.3.3.44 - Utah (UT)
3.3.3.45 - Vermont (VT)
3.3.3.46 - Virginia (VA)
3.3.3.47 - Washington (WA)
3.3.3.48 - West Virginia (WV)
3.3.3.49 - Wisconsin (WI)
3.3.3.50 - Wyoming
3.4 - INTERNATIONAL AGREEMENTS
3.4.1 - Memoranda of Understanding
3.4.2 - MUTUAL RECOGNITION AGREEMENTS
3.4.2.1 - European Community
3.4.2.2 - Pharmaceuticals and Medical Devices
3.4.2.3 - Food Products
3.5 - NON GOVERNMENT AGREEMENTS
3.5.1 - Association of Official Analytical Chemists (AOAC)
3.5.2 - National Conference on Interstate Milk Shipments (NCIMS)
3.5.3 - Interstate Shellfish Sanitation Conference (ISSC)
3.5.4 - United States Pharmacopoeia Convention (USP)
3.5.5 - Conference for Food Protection (CFP)
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