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CVB Inspection and Compliance Manual

This policy manual represents the Center for Veterinary Biologics (CVB) current thinking on these topics. It does not create or confer any rights for, or on any person, and does not operate to bind CVB or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the CVB staff responsible for implementing these policies.

1.     INTRODUCTION

  • History

2.     AUTHORITIES FOR THE BIOLOGICS PROGRAM

3.     INSPECTION OF ESTABLISHMENTS - Principles (In process)

  • Refusal of Entry for Inspection, Assault, and Bribery Procedures - ICSOP0028

4.     INVESTIGATION AND PROCESSING ALLEGED VIOLATIONS - ICSOP0016 (June 27, 2011- 459 KB)

5.     PHARMACOVIGILANCE OF VETERINARY BIOLOGICAL PRODUCTS

6.     PROCESSING SERIAL RECORDS

7.     PRODUCT SAMPLING - ICSOP0022 (July 5, 2017)

  • Reference Slip - Product Sample Submission

8.     PRODUCT DESTRUCTION - ICSOP0005 (June 27, 2011)

9.     PROCESSING FACILITY DOCUMENTS - ICSOP0018 (October 6, 2017)

  • General Information

10.     PROCESSING AUDITS FOR APHIS FORMS 2008 and 2071 (In process)

  • Approval of Alternate Form 2008 - ICWI0002

11.     INSPECTION OF A FOREIGN ESTABLISHMENT (In process)

12.     DEPOSITION, SUBPOENAS, INFORMAL CONFERENCE AND LEGISLATIVE INQUIRY PROCEDURES

13.     SAFETY AND HEALTH

14.     INSPECTION AND COMPLIANCE POLICIES

15.     GENERAL OFFICE GUIDELINES

16.     REFUSAL OF ENTRY, ASSAULT AND BRIBERY PROCEDURES 

  • USDA Secretary’s Memorandum 4430-2

  • USDA Departmental Regulation 4200-001

  • USDA Handbook on Workplace Violence Prevention and Response

  • APHIS Form 259-R, Workplace Incident Report

  • USDA Ethics Training

17.     GENERAL COMPUTER GUIDELINES 

  • CVB Inspection and Compliance Policy Concerning Email Message Regarding Trade Secrets Act - CVBWI0215

18.     EXPORT ACTIVITIES

19.     MISCELLANEOUS 

  • The Inspection and Compliance Review Process for Veterinary Biologics Program Documentation Intended for Publication - ICSOP0002

  • Calculation and Reporting of Inspection and Compliance Workload Indicators - ICSOP0027

 

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