IOM: Chapter 2 Regulatory Table of Contents

Inspection References
Investigations Operations Manual 2008

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2.1 - REGULATORY NOTES
2.1.1 - USES OF REGULATORY NOTES
2.1.2 - REGULATORY NOTES CHARACTERISTICS
2.1.3 - REGULATORY ENTRIES
2.1.4 - FORMAT FOR REGULATORY NOTES
2.1.5 - RETENTION OF REGULATORY NOTES
2.2 - STATUTORY AUTHORITY
2.2.1 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
     2.2.1.1 - Authority to Enter and Inspect
     2.2.1.2 - Food Inspections
     2.2.1.3 - Device Inspections
     2.2.1.4 - Limitations
     2.2.1.5 - Electronic Radiation Product Examinations and Inspections
2.2.2 - SELECTED AMENDMENTS TO THE FD&C ACT
2.2.3 - OTHER ACTS
     2.2.3.1 - Anabolic Steroids Control Act of 1990
     2.2.3.2 - Fair Packaging and Labeling Act (FPLA)
     2.2.3.3 - Federal Anti-Tampering Act
     2.2.3.4 - Federal Import Milk Act
     2.2.3.5 - Federal Caustic Poison Act
     2.2.3.6 - Poison Prevention Packaging Act
     2.2.3.7 - Public Health Service Act (PHS)
     2.2.3.8 - Mammography Quality Standards Act of 1992
2.2.4 - CODE OF FEDERAL REGULATIONS (CFR)
2.2.5 - DEFINITIONS
     2.2.5.1 - Civil Number
     2.2.5.2 - Citation (Cite)
     2.2.5.3 - Criminal Number
     2.2.5.4 - FDC and INJ Numbers
     2.2.5.5 - Complaint For Forfeiture
     2.2.5.6 - Home District
     2.2.5.7 - Nolle Prosequi (Nol-Pros)
     2.2.5.8 - Nolo Contendere (Nolo)
     2.2.5.9 - Seizing District
     2.2.5.10 - Subpoena Duces Tecum
     2.2.5.11 - Supervising District
2.2.6 - SEIZURE
     2.2.6.1 - District Recommendation
     2.2.6.2 - Headquarters
     2.2.6.3 - Department of Justice
     2.2.6.4 - U.S. District Court
     2.2.6.5 - Claimant and Options
     2.2.6.6 - Abandonment
     2.2.6.7 - Reconditioning for Compliance
     2.2.6.8 - Contested Seizure
     2.2.6.9 - District Follow-up
2.2.7 - PROSECUTION
     2.2.7.1 - Section 305 Notice
     2.2.7.2 - Information
     2.2.7.3 - Grand Jury Proceedings
     2.2.7.4 - District Follow-up
2.2.8 - INJUNCTION
     2.2.8.1 - Temporary Restraining Order (TRO)
     2.2.8.2 - Hearing for Injunction
     2.2.8.3 - Consent Decree of Injunction
     2.2.8.4 - Trial for Injunction
     2.2.8.5 - Preliminary or Permanent Injunction
     2.2.8.6 - District Follow-up
2.2.9 - EMERGENCY PERMIT CONTROL
2.2.10 - DETENTION POWERS
2.2.11 - COURTROOM TESTIMONY
     2.2.11.1 - Testimony Preparation
     2.2.11.2 - Interviewing Persons Under Arrest
2.3 - RECONDITIONING AND DISTRUCTION
2.3.1 - DEFINITIONS
     2.3.1.1 - Reconditioning
     2.3.1.2 - Destruction
     2.3.1.3 - Denaturing
2.3.2 - DISASTERS
2.4 - CONSENT DECREE
2.4.1 - POLICY
2.4.2 - RELABELING
2.4.3 - REWORKING
2.4.4 - SEGREGATION
2.4.5 - DESTRUCTION
2.4.6 - DISPOSITION OF REJECTS
2.4.7 - RELEASE OF GOODS
2.4.8 - REPORTING
2.5 - DEFAULT DECREE
2.5.1 - POLICY
2.5.2 - REPORTING
2.6 - COMPLIANCE ACHIEVEMENT
2.6.1 - POLICY
2.6.2 - DESTRUCTION
     2.6.2.1 - DEA Controlled Drugs
        2.6.2.1.1 - DEA Approval
        2.6.2.1.2 - Procedure
2.6.3 - RECONDITIONING
2.6.4 - REPORTING
     2.6.4.1 - Documenting Voluntary Destruction
     2.6.4.2 - Compliance Achievement Reporting
        2.6.4.2.1 - Violative Products
        2.6.4.2.2 - Destruction by Cooperating Officials
        2.6.4.2.3 - Manufacturer's Raw Materials
        2.6.4.2.4 - Capital Improvements
        2.6.4.2.5 - Correction of GMP Deviations
        2.6.4.2.6 - Formula/Label Correction
        2.6.4.2.7 - Additional Personnel
        2.6.4.2.8 - Educational and/or Training
        2.6.4.2.9 - Items Not Reported in FACTS
2.7 - DETENTION ACTIVITIES
2.7.1 - OVERVIEW AND AUTHORITY
     2.7.1.1 - Overview
        2.7.1.1.1 - Accomplishing a Detention
        2.7.1.1.2 - Detention Of Medical Devices
        2.7.1.1.3 - Detention of Foods
        2.7.1.1.4 - Detention Procedural Steps
     2.7.1.2 - Authorities
        2.7.1.2.1 - Food Drug and Cosmetic Act
        2.7.1.2.2 - Federal Meat Inspection Act
        2.7.1.2.3 - Poultry Products Inspection Act
        2.7.1.2.4 - Egg Products Inspection Act
     2.7.1.3 - Definitions
        2.7.1.3.1 - Device
        2.7.1.3.2 - FOOD
        2.7.1.3.3 - PERISHABLE FOOD
        2.7.1.3.4 - MEAT PRODUCTS AND POULTRY PRODUCTS (DUAL JURISDICTION)
        2.7.1.3.5 - EGG AND EGG PRODUCTS (DUAL JURISDICTION)
2.7.2 - INSPECTIONAL PROCEDURE
     2.7.2.1 - Criteria for Detention
        2.7.2.1.1 - Devices
        2.7.2.1.2 - FOOD
        2.7.2.1.3 - Meat and Poultry Products
        2.7.2.1.4 - Egg and Egg Products
     2.7.2.2 - Detention Procedure
        2.7.2.2.1 - CONSIDERATIONS
        2.7.2.2.2 - EXECUTING the Detention
     2.7.2.3 - Detention Notice FDA 2289
        2.7.2.3.1 - Preparation of Detention Notice
        2.7.2.3.2 - Preparation of Page 1 (FDA 2289)
        2.7.2.3.3 - Preparation of Page 2 through 5 (FDA-2289)
        2.7.2.3.4 - Distribution of FDA-2289
     2.7.2.4 - Detention Tag FDA 2290
        2.7.2.4.1 - Preparation
        2.7.2.4.2 - Front of Tag
        2.7.2.4.3 - Reverse of Tag
        2.7.2.4.4 - Use of Tag
     2.7.2.5 - Termination of Detention
        2.7.2.5.1 - Removal of Detention Tags
        2.7.2.5.2 - Issuance of Detention Termination Notice FDA 2291
2.7.3 - SAMPLING
2.7.4 - SUPERVISION OF RECONDITIONING, DENATURING, OR DESTRUCTION
2.7.5 - REPORTING
2.8 - DENATURING
2.8.1 - OBJECTIVE
2.8.2 - DIVERSION TO ANIMAL FEED
     2.8.2.1 - Rodent or Bird Contaminated Foods
     2.8.2.2 - Moldy Food
     2.8.2.3 - Pesticide Contamination
2.8.3 - DECHARACTERIZATION FOR NON-FOOD OR FEED PURPOSES
2.9 - REGULATORY SUBMISSIONS
2.9.1 - CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
     2.9.1.1 - Registration and Listing
     2.9.1.2 - Investigational New Drug Application (IND)
     2.9.1.3 - New Drug Application (NDA)
     2.9.1.4 - Abbreviated New Drug Application (ANDA)
2.9.2 - CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)
     2.9.2.1 - Device Registration and Listing
     2.9.2.2 - Investigational Device Exemption (IDE) Regulation
     2.9.2.3 - Premarket Notification - Section 510(k)
     2.9.2.4 - Premarket Approval
     2.9.2.5 - Classification of Devices
        2.9.2.5.1 - Class I
        2.9.2.5.2 - Class II
        2.9.2.5.3 - Class III
     2.9.2.6 - Requests for GMP Exemption and Variances
     2.9.2.7 - Medical Device Reporting
     2.9.2.8 - Radiation Reporting
2.9.3 - CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)
     2.9.3.1 - Registration and Listing
        2.9.3.1.1 - Human Blood and Blood Products
        2.9.3.1.2 - Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
     2.9.3.2 - Biologic License
2.9.4 - CENTER FOR VETERINARY MEDICINE (CVM)
     2.9.4.1 - Registration and Listing
     2.9.4.2 - Medicated Feed Mill License (FML)
     2.9.4.3 - Abbreviated New Animal Drug Application (ANADA)
     2.9.4.4 - New Animal Drug Application (NADA)
2.9.5 - CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN)
     2.9.5.1 - Low Acid Canned Food (LACF) / Acidified Foods (AF) Food Canning Establishment (FCE) Registration
     2.9.5.2 - FCE Process Filing of LACF/AF Processors
     2.9.5.3 - Cosmetics
     2.9.5.4 - Color Certification Program
     2.9.5.5 - Infant Formula
     2.9.5.6 - Interstate Certified Shellfish (Fresh and Frozen Oysters, Clams, and Mussels) Shippers
     2.9.5.7 - Interstate Milk Shippers (IMS)

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