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Compliance References
Regulatory Procedures Manual 2008
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Chapter 10 Other Procedures

This chapter includes the following sections:

10-1 - COMMUNICATIONS - DISTRICT AND CENTER RESPONSIBILITIES
     10-1-1 - Regulatory Actions that Require Center Concurrence
     10-1-2 - Regulatory Actions prepared by a Center for District Issuance and/or Follow-up
10-2 - PRIOR NOTICE
     10-2-1 - Purpose
     10-2-2 - Background
     10-2-3 - Policy
     10-2-4 - Procedures
10-3 - REGULATORY MEETINGS
10-4 - INSPECTION OF FOOD RECORDS - SECTIONS 414(a) and 704(a)
     10-4-1 - Purpose
     10-4-2 - Authority
     10-4-3 - Criteria for Invoking Records Inspection Authority
     10-4-4 - Records that may be accessed and copied under this authority
     10-4-5 - Records that may not be accessed and copied under this authority
     10-4-6 - Procedure for Invoking Records Inspection Authority
     10-4-7 - Issuing the FDA 482c
     10-4-8 - Timeframes for compliance
     10-4-9 - Failure to provide records
10-5 - ESTABLISHMENT INSPECTION REPORT (EIR) CONCLUSIONS AND DECISIONS
10-6 - INTERSTATE TRAVEL PROGRAM (ITP) CLASSIFICATIONS AND ADMINISTRATIVE ACTIONS
10-7 - REPORTING AND MONITORING
10-8 - AD HOC COMMITTEE
     10-8-1 - Purpose
     10-8-2 - Background
     10-8-3 - Function
     10-8-4 - Composition
     10-8-5 - Procedures
     10-8-6 - Responsibilities
10-9 - APPEAL PROCESS
     10-9-1 - Purpose
     10-9-2 - Who May Appeal
     10-9-3 - What May Be Appealed
     10-9-4 - When An Appeal Is Not Appropriate
     10-9-5 - Requests For Appeal
     10-9-6 - Review Of Appeals
     10-9-7 - Decision On Appeals
10-10 - EXPERT SUPPORT FOR CASES
     10-10-1 - Purpose
     10-10-2 - Responsibility
     10-10-3 - Criteria For Determining The Level Of Expert Support
     10-10-4 - Documentation
     10-10-5 - List Of Individuals For Expert Support
     10-10-6 - Obtaining And Paying For Expert Support
10-11 - TESTIMONY; PRODUCTION OF RECORDS; CERTIFICATION OF RECORDS
     10-11-1 - Requests for Testimony
     10-11-2 - Requests for Production of Records
     10-11-3 - Multi-issue Subpoena - Requests for Samples
     10-11-4 - Requests for Certification of Records
     10-11-5 - Requests involving Special Circumstances
     10-11-6 - Disclosure of Non-public information
     10-11-7 - Other Requests for Information – Informal Meetings
     10-11-8 - Definitions
     10-11-9 - References
10-12 - APPLICATION INTEGRITY POLICY
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