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Inspections, Compliance, Enforcement, and Criminal Investigations
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Chapter 1 - General
Sub Chapter 100 - General
Sub Chapter 110 - Exports/Imports
Sub Chapter 120 - Fraud
Sub Chapter 130 - Inspections
Sub Chapter 140 - Labeling
Sub Chapter 150 - Laboratory/Analytic
Sub Chapter 160 - Regulatory
Sub Chapter 170 - Specific Problems Non-Food, Drug, or Cosmetic Related
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Sub Chapter 100 - General
- CPG Sec. 100.100 Responsibility for Reporting Possible or Potential Violations of Laws Administered by FDA, Regulations Issued by FDA, Other Possible or Potential Hazards to the Public Health
- CPG Sec. 100.200 FDA Jurisdiction Over Products Composed of Interstate Ingredients
- CPG Sec. 100.300 *Non-FDA Regulated Products Involving Communicable Disease Hazards*
- CPG Sec. 100.350 FDA Jurisdiction on Indian Reservations
- CPG Sec. 100.500 - Common Carrier as a Relabeler, Repacker, Reprocessor, etc.
- CPG Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices
- CPG Sec. 100.600 Status of Facial Tissues, Paper Napkins, Paper Towels and Similar Paper Products
- CPG Sec. 100.700 GWQAP Pre-Award Evaluation - Inadequate Information to Evaluate Prospective Supplier
- CPG Sec. 100.800 Guaranties Over Printed Signatures
- CPG Sec. 100.900 International Memoranda of Understanding
- CPG Sec. 100.950 International Partnership Agreements for Compliance Activities
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Sub Chapter 110 - Exports/Imports
- CPG Sec. 110.100 Certification for Exports
- CPG Sec. 110.200 Export of FDA Regulated Products from U.S. Foreign Trade Zones
- CPG Sec. 110.300 Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
- Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
- CPG Sec. 110.500 Food and Drug Guaranty - Imports
- CPG Sec. 110.600 FDA Authority Over Products of Foreign Origin Located in Foreign Trade Zones, Bonded Warehouses or on Bonded Carriers
- CPG Sec. 110.700 Seizures by the U.S. Customs Service of Prohibited Articles of Foreign Origin Not Intended for Entry into the United States
- CPG Sec. 110.800 Imports, Post Detention Sampling
- CPG Sec. 110.900 Imported Products - Lack of English Labeling
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Sub Chapter 120 - Fraud
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Sub Chapter 130 - Inspections
- CPG Sec. 130.100 Inspectional Authority; Refusal to Permit Inspection.
- CPG Sec. 130.200 Inspection of Firms when Legal Action is Pending
- CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections
- CPG Sec. 130.400 Use of Microfiche and/or Microfilm for Method of Records Retention
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Sub Chapter 140 - Labeling
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Sub Chapter 150 - Laboratory/Analytic
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Sub Chapter 160 - Regulatory
- CPG Sec. 160.100 Regulatory Actions and Small Business
- CPG Sec. 160.200 FDA Use of Income Tax Information from IRS in Compliance Activity
- CPG Sec. 160.300 Requests for Records Under Section 703
- CPG Sec. 160.400 *Section 305 Meeting* Before Report of Criminal Violation
- CPG Sec. 160.500 Answering Inquiries on Status of Criminal Referrals
- CPG Sec. 160.600 Payment of Expert Witnesses
- CPG Sec. 160.700 Reconditioning of Foods Adulterated Under 402(a)(4)
- CPG Sec. 160.750 Drug and Device Products (Including Biologics and Animal Drugs) Found in Violation of GMPRs - Reconditioning
- CPG Sec. 160.800, Year 2000 (Y2K) Computer Compliance
- Compliance Policy Guide Sec. 160.850: Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures (Compliance Policy Guide 7153.17)
- CPG Sec. 160.900 Prescription Drug Marketing Act -- Pedigree Requirements under 21 CFR Part 203
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Sub Chapter 170 - Specific Problems - Non-Food, Drug, or Cosmetic Related
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