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Inspection References
Investigations Operations Manual 2004
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Chapter 4 - SAMPLING

SUBCHAPTER 400 - GENERAL
401 - AUTHORITY
     401.01 - Examinations and Investigations
     401.02 - Notice of Inspection
     401.03 - Receipt for Sample
     401.06 - Report of Analysis
402 - VALID SAMPLE
404 - RESPONSIBILITY
405 - OFFICIAL SAMPLES (21 CFR 2.10)
     405.01 - Definition - Official Sample
     405.02 - Documentary Samples
     405.03 - In-Transit Samples
     405.04 - 301(k) Samples
     405.05 - Induced Sample
     405.06 - Undercover Buy
     405.07 - Post Seizure (P.S.) Sample
     405.08 - Domestic Import Sample
     405.09 - Import Sample
     405.10 - Additional Sample
406 - FOOD STANDARDS SAMPLE
407 - GWQAP SAMPLES
408 - INVESTIGATIONAL SAMPLES
     408.01 - Audit/Certification Sample
     408.02 - Mail Entry Sample
     408.03 - Non-Regulatory Sample
SUBCHAPTER 410 - DEALER RELATIONS
410.01 - Dealer Definition and Good Will
     410.02 - Dealer Objection to Sampling Procedure
     410.03 - Refusal to Permit Sampling
411 - NOTICE OF INSPECTION
     411.01 - Dealer Responsible For Condition of Lot
     411.02 - Refusals
     411.03 - Carrier In-transit Sampling
     411.04 - Dealer Requests Notice of Inspection
412 - RECEIPT FOR SAMPLES
     412.01 - Carriers/In-Transit Lots
     412.02 - Dealer Requests Receipt
     412.04 - Narcotic and Controlled Rx Drugs
     412.05 - Prescription Drugs (Non-Controlled)
     412.06 - Preparation of FDA 484
     412.07 - Routing of FDA 484
414 - DEALER IDENTIFICATION OF LOT AND RECORDS
     414.02 - Private Individuals
     414.03 - Seriously Ill Individuals
415 - SAMPLING FROM GOVERNMENT AGENCIES
416 - PAYMENT FOR SAMPLES
     416.01 - Post Seizure (P.S.) and Reconditioning Samples Under Court Order
     416.02 - Determining Sample Cost
     416.03 - Method of Payment
     416.04 - Sampling - Labor Charges
418 - VOLUNTARY EMBARGO
     418.01 - Perishable Goods
     418.02 - Obtaining a Voluntary Embargo
SUBCHAPTER 420 - COLLECTION TECHNIQUE
420.01 - Responsibility
421 - LOT RESTORATION & IDENTIFICATION
     421.01 - Restoring Lot(s) Sampled
     421.02 - Identifying Lot(s) Sampled
422 - SAMPLE SIZE
     422.01 - Medical Device Samples
     422.02 - 702(b) Requirement
     422.03 - Collecting the 702(b) Portion
424 - IN-TRANSIT SAMPLES
425 - SPECIAL SAMPLING SITUATIONS
     425.01 - Complaints, Counterfeiting / Tampering, Foodborne Disease, Injury Illness
     425.02 - Recalls
     425.03 - Natural Disasters
     425.04 - Induced Samples
     425.05 - Undercover Buy
426 - ASEPTIC SAMPLE
     426.01 - General Procedures
     426.02 - Sampling Dried Powders
     426.03 - Collecting Water Samples
     426.04 - Sample Handling
     426.05 - Controls
427 - ADULTERATION VIOLATIONS
     427.01 - Field Examination
     427.02 - Random Sampling
     427.03 - Selective Sampling
     427.04 - Sample Criteria
     427.05 - Abnormal Containers
     427.06 - In-Line Samples
     427.07 - Products Susceptible to Contamination with Pathogenic Microorganisms
     427.08 - Samples for Viral Analysis
428 - ECONOMIC VIOLATIONS
     428.01 - Net Weight
     428.02 - Volume Determination
     428.03 - Labeling
429 - ORGANOLEPTIC EXAMINATIONS
     429.01 - Whole-Bag Screening
SUBCHAPTER 430 - DOCUMENTATION & CR
     430.01 - Authority
     430.02 - Objective
     430.03 - Policy
     430.04 - Responsibility
     430.05 - Sample Records Identification
431 - EVIDENCE REQUIRED
     431.01 - Seizure
     431.02 - Injunction or Criminal Prosecution
     431.03 - Complaint or Injury Samples
432 - DOCUMENTING INTERSTATE SHIPMENTS
     432.01 - Sales Records
     432.02 - Transportation Records for Common Carrier Shipments
     432.03 - Mail or Parcel Service Shipments.
     432.04 - Shipment by Privately-Owned Conveyance
     432.05 - In-Transit Sampling Affidavit
433 - AFFIDAVITS
     433.01 - Affidavit (Dealer/Warehouseman)
     433.02 - Affidavit (FDA 463a)
     433.03 - Affidavit (Jobber)
435 - LABELS AND LABELING
     435.01 - Labels & Accompanying Labeling
     435.02 - Bulk Shipments
     435.03 - Unlabeled or Partially Labeled Lot
439 - REPORTING SAMPLE COLLECTIONS
     439.01 - Flag
     439.02 - Type Identification
     439.08 - Preparation
     439.09 - Routing
SUBCHAPTER 450 - SAMPLING: PREPARATION, HANDLING, SHIPPING
     450.01 - Objective
451 - IDENTIFYING MARKS
     451.01 - Sub Samples
     451.02 - Borrowed Samples
     451.03 - Identification Techniques
     451.04 - Photographs
     451.05 - Records - Accompanying Literature and Exhibits
452 - SAMPLE HANDLING
     452.01 - Fumigation
     452.02 - Labeling
     452.03 - Samples for Pathological Examination
     452.04 - Small Sample Items
     452.05 - Frozen Samples
     452.06 - Refrigerated (Not Frozen) Samples
453 - OFFICIAL SEALS
     453.01 - Preparation
     453.02 - Application
     453.03 - Sealing Method
     453.04 - Protecting the Official Seal
     453.05 - Broken Official Seals and "Temporary Seals"
     453.06 - Metal Seals
     453.07 - Sealing Non-Sample Items
454 - SAMPLE SHIPMENT
     454.01 - Sample Package Identification
     454.02 - Routing of Samples
     454.03 - Samples to Administration Laboratories
     454.04 - Sample Shipment to Outside Agencies
     454.05 - Notifying Receiving Laboratories
     454.06 - Method of Shipment
     454.07 - Parcel Post
     454.08 - Common Carrier
     454.09 - Certified and First Class Mail
455 - PAYMENT OF SHIPPING CHARGES

SAMPLE SCHEDULE CHARTS 1-10
  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

 

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