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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
- SALMONELLA SAMPLING PLAN
- SAMPLING SCHEDULE FOR CANNED AND ACIDIFIED FOODS
- PESTICIDE SAMPLES
- WHEAT CARLOAD SAMPLING
- IMPORTED WHITEFISH SAMPLING SCHEDULE
- MYCOTOXIN SAMPLE SIZES
- CANNED FRUIT - FILL OF CONTAINER - AUTHENTIC PACK
- IMPORTS - COFFEE, DATES AND DATE MATERIAL
- SAMPLING SCHEDULE FOR COLOR CONTAINING PRODUCTS COLOR ADDITIVES
- Drug Sampling Schedules
(Does not include Antibiotic Preparations)
- VETERINARY PRODUCTS,
FEEDS, & BY-PRODUCTS FOR ANIMAL FEEDS
- MEDICATED ANIMAL FEEDS SAMPLING
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