Inspections, Compliance, Enforcement, and Criminal Investigations
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Chapter 1 - General
Sub Chapter 110 - Exports/Imports
Sub Chapter 150 - Laboratory/Analytic
Sub Chapter 170 - Specific Problems Non-Food, Drug, or Cosmetic Related
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Sub Chapter 100 - General
- Compliance Policy Guide 7150.05 sec. 100.100
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 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 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 CPG Sec. 160.850: Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures CPG Sec. 160.900 Prescription Drug Marketing Act -- Pedigree Requirements under 21 CFR Part 203
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