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Inspection References
Investigations Operations Manual 2008
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Contents

4.1 - GENERAL
4.1.1 - AUTHORITY
     4.1.1.1 - Examinations and Investigations
     4.1.1.2 - Notice of Inspection
     4.1.1.3 - Receipt for Sample
     4.1.1.4 - Report of Analysis
4.1.2 - VALID SAMPLE
4.1.3 - RESPONSIBILITY
4.1.4 - OFFICIAL SAMPLES (21 CFR 2.10)
     4.1.4.1 - Definition - Official Sample
     4.1.4.2 - Documentary Samples
     4.1.4.3 - In-Transit Samples
     4.1.4.4 - 301(k) Samples
     4.1.4.5 - Induced Sample
     4.1.4.6 - Undercover Buy
     4.1.4.7 - Post Seizure (P.S.) Sample
     4.1.4.8 - Domestic Import Sample
     4.1.4.9 - Import Sample
     4.1.4.10 - Additional Sample
4.1.5 - FOOD STANDARDS SAMPLE
4.1.6 - GWQAP SAMPLES
4.1.7 - INVESTIGATIONAL SAMPLES
     4.1.7.1 - Audit/Certification Sample
     4.1.7.2 - Mail Entry Sample
     4.1.7.3 - Non-Regulatory Sample
4.2 - DEALER RELATIONS
4.2.1 - Dealer Definition and Good Will
4.2.2 - Dealer Objection to Sampling Procedure
4.2.3 - Refusal to Permit Sampling
4.2.4 - NOTICE OF INSPECTION
     4.2.4.1 - Dealer Responsible For Condition of Lot
     4.2.4.2 - Refusals
     4.2.4.3 - Carrier In-Transit Sampling
     4.2.4.4 - Dealer Requests Notice of Inspection
4.2.5 - RECEIPT FOR SAMPLES
     4.2.5.1 - Carriers/In-Transit Lots
     4.2.5.2 - Dealer Requests Receipt
     4.2.5.3 - Narcotic and Controlled Rx Drugs
     4.2.5.4 - Prescription Drugs (Non-Controlled)
     4.2.5.5 - Preparation of FDA 484
     4.2.5.6 - Routing of FDA 484
4.2.6 - DEALER IDENTIFICATION OF LOT AND RECORDS
     4.2.6.1 - Private Individuals
     4.2.6.2 - Seriously Ill Individuals
4.2.7 - SAMPLING FROM GOVERNMENT AGENCIES
4.2.8 - PAYMENT FOR SAMPLES
     4.2.8.1 - Post Seizure (P.S.) and Reconditioning Samples Under Court Order
     4.2.8.2 - Determining Sample Cost
     4.2.8.3 - Method of Payment
        4.2.8.3.1 - Costs Billed to District
        4.2.8.3.2 - Cash Payment
     4.2.8.4 - Sampling - Labor Charges
4.2.9 - VOLUNTARY EMBARGO
     4.2.9.1 - Perishable Goods
     4.2.9.2 - Obtaining a Voluntary Embargo
4.3 - COLLECTION TECHNIQUE
4.3.1 - Responsibility
4.3.2 - LOT RESTORATION & IDENTIFICATION
     4.3.2.1 - Restoring Lot(s) Sampled
     4.3.2.2 - Identifying Lot(s) Sampled
4.3.3 - SAMPLE SIZE
     4.3.3.1 - Medical Device Samples
     4.3.3.2 - 702(b) Requirement
     4.3.3.3 - Collecting the 702(b) Portion
4.3.4 - IN-TRANSIT SAMPLES
     4.3.4.1 - Examination without a Warrant
     4.3.4.2 - Examination with a Warrant
     4.3.4.3 - Resealing Conveyances
4.3.5 - SPECIAL SAMPLING SITUATIONS
     4.3.5.1 - Complaints, Counterfeiting / Tampering, Foodborne Disease, Injury Illness
     4.3.5.2 - Recalls
     4.3.5.3 - Natural Disasters
     4.3.5.4 - Induced Samples
     4.3.5.5 - Undercover Buy
4.3.6 - ASEPTIC SAMPLE
     4.3.6.1 - General Procedures
        4.3.6.1.1 - Sterilized Equipment
        4.3.6.1.2 - Cautions
        4.3.6.1.3 - Opening Sterile Sampling Containers
        4.3.6.1.4 - Dusty Areas
     4.3.6.2 - Sampling Dried Powders
        4.3.6.2.1 - Bag and Poly-liner Stitched Together Across Top Seam
        4.3.6.2.2 - Bag Stitched Across Top and Poly-liner Twist-Closed and Sealed with "twist" Device - Wire, Plastic, etc.
        4.3.6.2.3 - Bags with Filling Spouts
     4.3.6.3 - Collecting Water Samples
     4.3.6.4 - Sample Handling
     4.3.6.5 - Controls
4.3.7 - ADULTERATION VIOLATIONS
     4.3.7.1 - Field Examination
     4.3.7.2 - Random Sampling
     4.3.7.3 - Selective Sampling
     4.3.7.4 - Sample Criteria
        4.3.7.4.1 - General
        4.3.7.4.2 - Rodent Contamination
           4.3.7.4.2.1 - Examination and Documentation of Rodent Contamination
           4.3.7.4.2.2 - Collecting Exhibits or Subsamples
           4.3.7.4.2.3 - Summary of Sample For Rodent Evidence
        4.3.7.4.3 - Insect Contamination
           4.3.7.4.3.1 - Examination and Documentation of Insect Contamination
           4.3.7.4.3.2 - Collecting Exhibits or Subsamples
           4.3.7.4.3.3 - Summary of sample for insect evidence
        4.3.7.4.4 - Bird Contamination
           4.3.7.4.4.1 - Examination and Documentation of Bird Contamination
           4.3.7.4.4.2 - Collecting Exhibits and Subsamples
           4.3.7.4.4.3 - Summary of Sample for Bird Evidence
        4.3.7.4.5 - Chemical Contamination
        4.3.7.4.6 - Mold Contamination
     4.3.7.5 - Abnormal Containers
     4.3.7.6 - In-Line Samples
     4.3.7.7 - Products Susceptible to Contamination with Pathogenic Microorganisms
        4.3.7.7.1 - In-line sampling
        4.3.7.7.2 - Environmental Sampling
        4.3.7.7.3 - Finished Product Sampling
     4.3.7.8 - Samples for Viral Analysis
4.3.8 - ECONOMIC VIOLATIONS
     4.3.8.1 - Net Weight
        4.3.8.1.1 - Tare Determination
        4.3.8.1.2 - Field Examination
        4.3.8.1.3 - Field Weight Sheet
     4.3.8.2 - Volume Determination
        4.3.8.2.1 - Free Flowing Liquids
        4.3.8.2.2 - Viscous Liquids
     4.3.8.3 - Labeling
4.3.9 - ORGANOLEPTIC EXAMINATIONS
     4.3.9.1 - Whole-Bag Screening
4.4 - DOCUMENTATION & CR
4.4.1 - Authority
4.4.2 - Objective
4.4.3 - Policy
     4.4.3.1 - Collection Records
4.4.4 - Responsibility
4.4.5 - Sample Records Identification
4.4.6 - EVIDENCE REQUIRED
     4.4.6.1 - Seizure
     4.4.6.2 - Injunction or Criminal Prosecution
        4.4.6.2.1 - Introduction Into I.S.
        4.4.6.2.2 - Adulteration or Misbranding in Interstate Commerce
        4.4.6.2.3 - Receipt in I.S.
        4.4.6.2.4 - Manufacture Within a Territory
        4.4.6.2.5 - False Guaranty
        4.4.6.2.6 - Dealer Violation
     4.4.6.3 - Complaint or Injury Samples
4.4.7 - DOCUMENTING INTERSTATE SHIPMENTS
     4.4.7.1 - Sales Records
     4.4.7.2 - Transportation Records for Common Carrier Shipments
        4.4.7.2.1 - Refusal to Permit Access to Records in Possession of Common Carriers
        4.4.7.2.2 - Written Request for Records
        4.4.7.2.3 - Bill of Lading
        4.4.7.2.4 - Freight Bill
        4.4.7.2.5 - Waybill
     4.4.7.3 - Mail or Parcel Service Shipments.
     4.4.7.4 - Shipment by Privately-Owned Conveyance
     4.4.7.5 - In-Transit Sampling Affidavit
4.4.8 - AFFIDAVITS
     4.4.8.1 - General considerations for all affidavits
     4.4.8.2 - Refusal to Sign the Affidavit
     4.4.8.3 - Confidential Informants
     4.4.8.4 - Affidavit (Dealer/Warehouseman)
     4.4.8.5 - Affidavit (FDA 463a)
     4.4.8.6 - Affidavit (Jobber)
4.4.9 - LABELS AND LABELING
     4.4.9.1 - Labels & Accompanying Labeling
     4.4.9.2 - Bulk Shipments
     4.4.9.3 - Unlabeled or Partially Labeled Lot
        4.4.9.3.1 - Documentation
4.4.10 - REPORTING SAMPLE COLLECTIONS
     4.4.10.1 - Flag
        4.4.10.1.1 - 301(k) Sample
        4.4.10.1.2 - Complaint Sample
        4.4.10.1.3 - Dealer Voluntarily Holding
        4.4.10.1.4 - Exhibit Sample
        4.4.10.1.5 - Factory Food Sample
        4.4.10.1.6 - Fumigated
        4.4.10.1.7 - Inv. Samples of Filth Exhibits
        4.4.10.1.8 - Pesticide Sample
        4.4.10.1.9 - Reconditioned
        4.4.10.1.10 - Sampled in Transit
        4.4.10.1.11 - Split Sample
        4.4.10.1.12 - Survey Sample
        4.4.10.1.13 - Under State Embargo
     4.4.10.2 - Type Identification
        4.4.10.2.1 - Additional (ADD)
        4.4.10.2.2 - Audit/Certification
        4.4.10.2.3 - Documentary (DOC)
        4.4.10.2.4 - Domestic Import (DI)
        4.4.10.2.5 - Food Standards (FS)
        4.4.10.2.6 - Investigational (INV)
        4.4.10.2.7 - Mail Entry
        4.4.10.2.8 - Non-Regulatory
        4.4.10.2.9 - Official
        4.4.10.2.10 - Post Award (GQA)
        4.4.10.2.11 - Post Seizure (PS)
        4.4.10.2.12 - Regulatory
     4.4.10.3 - Preparation
        4.4.10.3.1 - Accomplishment Hours
        4.4.10.3.2 - Analytical Assignment
        4.4.10.3.3 - Brand Name
        4.4.10.3.4 - Carrier Name
        4.4.10.3.5 - Collection Date
        4.4.10.3.6 - Collection Method
        4.4.10.3.7 - Collection PACs
        4.4.10.3.8 - Collection Reason
        4.4.10.3.9 - Collection Remarks
        4.4.10.3.10 - Collector
        4.4.10.3.11 - Collector's ID on Package/Document
        4.4.10.3.12 - Collector's ID on Seal
        4.4.10.3.13 - Consumer Complaint Number
        4.4.10.3.14 - Country of Origin
        4.4.10.3.15 - County
        4.4.10.3.16 - CR & Records Sent to
        4.4.10.3.17 - CRx/DEA Schedule
        4.4.10.3.18 - Dairy Permit Number
        4.4.10.3.19 - Date Collected
        4.4.10.3.20 - Date Shipped
        4.4.10.3.21 - Documents Obtained
        4.4.10.3.22 - Episode Number
        4.4.10.3.23 - Estimated Value
        4.4.10.3.24 - FEI Number
        4.4.10.3.25 - Firm Name
        4.4.10.3.26 - Firm Type
           4.4.10.3.26.1 - Dealer
           4.4.10.3.26.2 - Grower
           4.4.10.3.26.3 - Harvester
           4.4.10.3.26.4 - Ingredient Supplier
           4.4.10.3.26.5 - Manufacturer
           4.4.10.3.26.6 - Shipper
        4.4.10.3.27 - FIS Sample Number
        4.4.10.3.28 - Food Canning Establishment
        4.4.10.3.29 - Hours
        4.4.10.3.30 - How Prepared
        4.4.10.3.31 - Lot Size
        4.4.10.3.32 - Manufacturing Codes
        4.4.10.3.33 - Method of Collection
        4.4.10.3.34 - National Drug Code
        4.4.10.3.35 - Orig CR & Records to
        4.4.10.3.36 - Payment Method
        4.4.10.3.37 - Permit Number
        4.4.10.3.38 - Product Code
        4.4.10.3.39 - Product Description
        4.4.10.3.40 - Product Label
        4.4.10.3.41 - Product Name
        4.4.10.3.42 - Reason for Collection
        4.4.10.3.43 - Recall Number
        4.4.10.3.44 - Receipt Issued
        4.4.10.3.45 - Receipt Type
        4.4.10.3.46 - Related Samples
        4.4.10.3.47 - Resp. Firm Type
        4.4.10.3.48 - Sample Basis
        4.4.10.3.49 - Sample Class
        4.4.10.3.50 - Sample Cost
        4.4.10.3.51 - Sample Delivered Date
        4.4.10.3.52 - Sample Delivered To
        4.4.10.3.53 - Sample Description
        4.4.10.3.54 - Sample Flags
        4.4.10.3.55 - Sample Number
        4.4.10.3.56 - Sample Origin
        4.4.10.3.57 - Sample Sent To
        4.4.10.3.58 - Sample Type
        4.4.10.3.59 - Sampling District
        4.4.10.3.60 - State
        4.4.10.3.61 - Status
        4.4.10.3.62 - Storage Requirements
        4.4.10.3.63 - 702(b) Portion Collected
        4.4.10.3.64 - 704(d) Sample
     4.4.10.4 - National Sample Distributor (NSD)
        4.4.10.4.1 - NSD AND ASSIGNMENTS
        4.4.10.4.2 - OVERRIDING NSD
        4.4.10.4.3 - OTHER INFORMATION
     4.4.10.5 - Routing
4.5 - SAMPLING: PREPARATION, HANDLING, SHIPPING
4.5.1 - Objective
4.5.2 - IDENTIFYING MARKS
     4.5.2.1 - Subsamples
     4.5.2.2 - Borrowed Samples
     4.5.2.3 - Identification Techniques
     4.5.2.4 - Photographs
     4.5.2.5 - Records - Accompanying Literature and Exhibits
4.5.3 - SAMPLE HANDLING
     4.5.3.1 - Fumigation
        4.5.3.1.1 - Fumigation Safety Precautions
        4.5.3.1.2 - Procedures for fumigation
        4.5.3.1.3 - Exceptions to Fumigation
        4.5.3.1.4 - Preservation Liquids
     4.5.3.2 - Labeling
     4.5.3.3 - Samples for Pathological Examination
     4.5.3.4 - Small Sample Items
     4.5.3.5 - Frozen Samples
        4.5.3.5.1 - Shipping Frozen Samples
        4.5.3.5.2 - Control
     4.5.3.6 - Refrigerated (Not Frozen) Samples
        4.5.3.6.1 - Control
4.5.4 - OFFICIAL SEALS
     4.5.4.1 - Preparation
     4.5.4.2 - Application
     4.5.4.3 - Sealing Method
     4.5.4.4 - Protecting the Official Seal
     4.5.4.5 - Broken Official Seals and "Temporary Seals"
     4.5.4.6 - Metal Seals
     4.5.4.7 - Sealing Non-Sample Items
4.5.5 - SAMPLE SHIPMENT
     4.5.5.1 - Sample Package Identification
     4.5.5.2 - Routing of Samples
     4.5.5.3 - Samples to Administration Laboratories
        4.5.5.3.1 - Split Samples
        4.5.5.3.2 - National Center for Drug Analysis or Headquarters' Division
        4.5.5.3.3 - Center for Food Safety and Applied Nutrition (CFSAN)
        4.5.5.3.4 - Center for Drug Evaluation and Research Division of Pharmaceutical Analysis (DPA)
        4.5.5.3.5 - Center for Biologics Evaluation and Research
        4.5.5.3.6 - Center for Devices and Radiological Health (CDRH)
        4.5.5.3.7 - Center for Veterinary Medicine
     4.5.5.4 - Sample Shipment to Outside Agencies
     4.5.5.5 - Notifying Receiving Laboratories
     4.5.5.6 - Method of Shipment
     4.5.5.7 - Parcel Post
     4.5.5.8 - Common Carrier
        4.5.5.8.1 - Shipment
        4.5.5.8.2 - Designated Carriers
        4.5.5.8.3 - Government Bill of Lading
        4.5.5.8.4 - Commercial Bill of Lading
        4.5.5.8.5 - Address Labels
        4.5.5.8.6 - Shipment of Hazardous or Toxic Items
        4.5.5.8.7 - Precautions
     4.5.5.9 - Certified and First Class Mail
4.5.6 - PAYMENT OF SHIPPING CHARGES

SAMPLE SCHEDULE CHARTS 1-13
  1. SALMONELLA SAMPLING PLAN
  2. SAMPLING SCHEDULE FOR CANNED AND ACIDIFIED FOODS
  3. PESTICIDE SAMPLES
  4. WHEAT CARLOAD SAMPLING
  5. IMPORTED WHITEFISH SAMPLING SCHEDULE
  6. MYCOTOXIN SAMPLE SIZES
  7. CANNED FRUIT - FILL OF CONTAINER - AUTHENTIC PACK
  8. IMPORTS - COFFEE, DATES AND DATE MATERIAL
  9. SAMPLING SCHEDULE FOR COLOR CONTAINING PRODUCTS COLOR ADDITIVES
  10. Drug Sampling Schedules (Does not include Antibiotic Preparations)
  11. VETERINARY PRODUCTS, FEEDS, & BY-PRODUCTS FOR ANIMAL FEEDS
  12. MEDICATED ANIMAL FEEDS SAMPLING
  13. Allergen Sample Schedule
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