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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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Contents
6.1 - IMPORTS
6.1.1 - AUTHORITY
6.1.2 - IMPORT INVESTIGATIONS
6.2 - IMPORT PROCEDURES
6.2.1 - SCOPE
6.2.2 - DIVISION OF AUTHORITY
6.2.3 - ENTRIES
6.2.3.1 - Formal Entries
6.2.3.2 - Informal Entries
6.2.3.3 - Mail/Personal Baggage
6.2.3.4 - Import for Export (IFE) Entries
6.2.3.4.1 - IFE Entry Review
6.2.3.4.2 - Domestic Follow-up
6.2.3.4.3 - Inspection Guidance
6.2.3.5 - Prior Notice of Importation of Food and Animal Feed
6.2.3.5.1 - Prior Notice Reception
6.2.3.5.2 - Products Requiring Prior Notice
6.2.3.5.3 - Products Excluded from Prior Notice
6.2.3.5.4 - Prior Notice Submission
6.2.3.5.5 - Inadequate Prior Notice Submission
6.2.3.5.6 - Prior Notice Process
6.2.3.6 - Entry Processing
6.2.3.6.1 - U. S. Customs
6.2.3.6.2 - FDA
6.2.4 - SAMPLING
6.2.4.1 - Ports Covered by FDA
6.2.4.2 - Ports not Covered by FDA
6.2.4.3 - Entry Sampling
6.2.4.4 - Notice Of Sampling
6.2.4.5 - Payment For Samples
6.2.5 - PROCEDURE WHEN PRODUCTS CANNOT BE SAMPLED OR EXAMINED
6.2.6 - PROCEDURE WHEN NO VIOLATION IS FOUND
6.2.7 - PROCEDURE WHEN VIOLATION IS FOUND
6.2.7.1 - "Notice of Detention & Hearing"
6.2.7.2 - Response To "Notice of Detention & Hearing"
6.2.7.3 - Request for Authorization to Relabel or Perform Other Acts
6.2.7.4 - Inspection After Completion of Authorization to Bring Article Into Compliance
6.2.7.5 - Procedure When Conditions of Authorization Have Been Fulfilled
6.2.7.6 - Procedure When Conditions of Reconditioning Have Not Been Fulfilled
6.2.7.7 - Procedure after hearing - "Notice of Release"
6.2.7.8 - Procedure after hearing - "Refusal of Admission"
6.2.7.9 - Payment of Costs of Supervision of Relabeling and/or Other Action
6.2.7.10 - Exportation of Merchandise Refused Admission
6.2.7.11 - Bond Action
6.3 - REVIEW OF RECORDS
6.3.1 - General
6.4 - FIELD EXAMINATION
6.4.1 - GENERAL
6.4.2 - FIELD EXAMINATION SCHEDULE
6.4.3 - FIELD EXAMINATIONS - FOODS
6.4.3.1 - Food Sanitation
6.4.3.2 - Pesticides, Industrial Chemicals, Aflatoxins, & Toxic Elements
6.4.3.3 - Food and Color Additives
6.4.3.4 - Nutrition and Nutrition Labeling
6.4.3.5 - Food Economics (On consumer size containers only)
6.4.3.6 - Cosmetics
6.4.4 - FIELD EXAMINATION - DRUGS
6.4.4.1 - Labeling
6.4.4.2 - Contamination
6.4.4.3 - Samples
6.4.4.4 - Special Instructions
6.4.5 - FIELD EXAMINATIONS - DEVICES
6.4.6 - FIELD EXAMINATIONS - BIOLOGICS
6.4.7 - FIELD EXAMINATIONS - VETERINARY PRODUCTS
6.4.7.1 - Drugs
6.4.7.2 - Devices
6.4.7.3 - Animal Feed
6.4.7.4 - Animal Grooming Aids
6.4.7.5 - Biologicals
6.4.8 - FIELD EXAMINATIONS RADIOLOGICAL HEALTH
6.5 - IMPORT SAMPLE COLLECTION
6.5.1 - GENERAL
6.5.2 - PROCEDURES
6.5.3 - TECHNIQUES
6.5.4 - IMPORT FORMS PROCEDURES
6.5.5 - SAMPLE COLLECTION REPORTS
6.5.5.1 - Collection Date
6.5.5.2 - Episode
6.5.5.3 - Submitted To
6.5.5.4 - Quantity Collected
6.5.5.5 - Units
6.5.5.6 - DescText
6.5.5.7 - Hand Ship
6.5.5.8 - Remarks
6.5.5.9 - Record Time Screen
6.6 - FILER EVALUATIONS
6.6.1 - GENERAL
6.7 - GLOSSARY OF IMPORT TERMS
6.7.1 - American Goods Returned
6.7.2 - BONDED WAREHOUSE
6.7.3 - BREAK-BULK CARGO
6.7.4 - CONSUMPTION ENTRY (CE)
6.7.5 - CONTAINER FREIGHT STATION (CFS)
6.7.6 - DATE COLLECTED
6.7.7 - DATE OF ARRIVAL
6.7.8 - DATE OF AVAILABILITY
6.7.9 - DETENTION
6.7.10 - DETENTION WITHOUT PHYSICAL EXAMINATION (DWPE)
6.7.11 - DOMESTIC IMPORT (DI) SAMPLE
6.7.12 - ENTRY
6.7.13 - ENTRY DOCUMENTS (ENTRY PACKAGE)
6.7.14 - FILER
6.7.15 - FORMAL ENTRY
6.7.16 - FOREIGN TRADE ZONES
6.7.17 - IMMEDIATE DELIVERY (ID) / CONDITIONAL RELEASE
6.7.18 - IMPORT ALERTS
6.7.19 - IMPORTER OF RECORD
6.7.20 - IMPORT SECTIONS
6.7.21 - IMPORT STATUS
6.7.22 - INFORMAL ENTRY
6.7.23 - IMMEDIATE TRANSPORTATION (IT)
6.7.24 - LINE (LINE ITEM)
6.7.25 - LOT
6.7.26 - MARKS
6.7.27 - PORT (POINT) OF ENTRY
6.7.28 - REDELIVERY BOND (AKA ENTRY BOND)
6.7.29 - STRIPPING (OF CONTAINERS)
6.7.30 - SUPERVISORY CHARGE
6.7.31 - WAREHOUSE ENTRY (WE)
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