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Investigations Operations Manual
Foreword
Ch 1 Administration
Ch 2 Regulatory
Ch 3 Federal-State Cooperation
Ch 4 Sampling
Sample Schedules
Ch 5 Establishment Inspection
Ch 6 Imports
Ch 7 Recall Activities
Ch 8 Investigations
Exhibits
Appendix
ORA Directory
Change Log
Search
Inspection References
Investigations Operations Manual 2008
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Contents
5.1 - INSPECTION INFORMATION
5.1.1 - AUTHORITY TO ENTER AND INSPECT
5.1.1.1 - FDA Investigator's Responsibility
5.1.1.2 - Credentials
5.1.1.3 - Written Notice
5.1.1.4 - Written Observations
5.1.1.5 - Receipts
5.1.1.6 - Written Demand for Records
5.1.1.7 - Written Requests for Information
5.1.1.7.1 - LACF / AF Inspections
5.1.1.7.2 - Request for Records Under Section 703 of the FD&C Act
5.1.1.8 - Business Premises
5.1.1.9 - Premises Used for Living Quarters
5.1.1.10 - Facilities where Electronic Products are Used or Held
5.1.1.11 - Multiple Occupancy Inspections
5.1.1.12 - Authority for Examinations and Investigations
5.1.1.13 - Authority to Implement Section 702(e)(5) of the FD&C Act
5.1.1.13.1 - Scope
5.1.1.13.2 - Inspectional Guidance
5.1.1.13.3 - Follow up Guidance
5.1.1.13.4 - Search Warrants
5.1.1.14 - Products Imported Under the Provisions of Section 801(d)(3) of the FD&C Act
5.1.1.14.1 - Requirements for the BT Act
5.1.1.14.2 - Inspectional Preparation
5.1.2 - INSPECTIONAL APPROACH
5.1.2.1 - Depth of Inspection
5.1.2.2 - Inspection Walk Through
5.1.2.3 - Signing Non-FDA Documents
5.1.2.4 - Technical Assistance
5.1.2.5 - Team Inspections
5.1.2.5.1 - Team Member Responsibilities
5.1.2.5.2 - Team Leader Responsibilities
5.1.3 - INSPECTION OF FOREIGN FIRMS
5.1.4 - INSPECTIONAL PRECAUTIONS
5.1.4.1 - Clothing
5.1.4.2 - PHS Recommendations - Basic Sanitary Practices
5.1.4.3 - Representatives Invited by the Firm to View the Inspection
5.1.5 - GENERAL PROCEDURES & TECHNIQUES
5.1.5.1 - Candling
5.1.5.2 - Label Review
5.1.5.3 - Field Exams
5.2 - INSPECTION PROCEDURES
5.2.1 - PRE-INSPECTIONAL ACTIVITIES
5.2.1.1 - Pre-Announcements
5.2.1.1.1 - Basic Premises
5.2.1.1.2 - Criteria for Consideration
5.2.1.1.2.1 - Type of Inspection
5.2.1.1.2.2 - Eligibility Criteria
5.2.1.1.3 - Procedures
5.2.1.2 - Personal Safety
5.2.1.2.1 - Preparation
5.2.1.2.2 - Physical Resistance/Threats/Assaults
5.2.1.3 - Personal Safety Alert
5.2.1.4 - Situational Plan
5.2.2 - NOTICE OF INSPECTION
5.2.2.1 - Multiple Date Inspections
5.2.2.2 - Inspection of Vehicles
5.2.2.3 - Follow-Up Inspections by Court Order
5.2.2.4 - Conducting Regulatory Inspections When the Agency is Contemplating Taking, or is Taking, Criminal Action
5.2.2.5 - When Evidence of a Criminal Violation is Discovered in the Course of a Regulatory Inspection
5.2.2.6 - Use of Evidence Gathered in the Course of a Criminal Investigation
5.2.2.7 - Use of Evidence Voluntarily Provided to the Agency
5.2.2.8 - Concurrent Administrative, Civil, and Criminal Actions
5.2.2.9 - Working with a Grand Jury
5.2.3 - REPORTS OF OBSERVATIONS
5.2.3.1 - Preparation Of Form FDA 483
5.2.3.1.1 - Individual Headings
5.2.3.1.2 - Signature Policy
5.2.3.1.3 - Date issued
5.2.3.1.4 - Observations
5.2.3.1.5 - Medical Device inspections
5.2.3.1.6 - Correction of FDA 483 Errors
5.2.3.1.6.1 - Errors discovered prior to leaving the establishment
5.2.3.1.6.2 - Errors discovered after leaving the establishment
5.2.3.2 - Reportable Observations
5.2.3.2.1 - Adulteration Observations
5.2.3.2.2 - Other Observations
5.2.3.3 - Non-Reportable Observations
5.2.3.4 - Annotation of the FDA 483
5.2.3.5 - Government Wide Quality Assurance Program (GWQAP)
5.2.3.6 - Distribution of the FDA 483
5.2.3.6.1 - Original
5.2.3.6.2 - Copies
5.2.4 - RECEIPT - FACTORY SAMPLES
5.2.4.1 - Items Requiring Receipt
5.2.4.2 - Items Not Requiring Receipt
5.2.5 - INSPECTION REFUSAL
5.2.5.1 - Refusal of Entry
5.2.5.2 - Refusal to Permit Access to or Copying of Records
5.2.5.3 - Refusal after Serving Warrant
5.2.5.4 - Hostile and Uncooperative Interviewees
5.2.5.4.1 - Indicators
5.2.5.4.2 - Safety Precautions
5.2.5.4.3 - Procedures when Threatened or Assaulted
5.2.5.4.4 - Notification of FBI and US Attorney
5.2.6 - INSPECTION WARRANT
5.2.7 - DISCUSSIONS WITH MANAGEMENT
5.2.7.1 - Protection of Privileged Information
5.2.7.2 - Refusals of Requested Information
5.2.8 - CONSUMER COMPLAINTS
5.2.9 - INTERVIEWING CONFIDENTIAL INFORMANTS
5.2.9.1 - How to handle the first contact
5.2.9.1.1 - Interviewing methods/techniques
5.2.9.1.2 - Establish motivation
5.2.9.1.3 - Anonymity
5.2.9.2 - Protect the identity of the source
5.2.9.2.1 - Access
5.2.9.2.2 - Storage Requirements
5.2.9.2.3 - Disclosure
5.2.9.2.4 - Destruction
5.2.10 - ROUTINE BIOSECURITY PROCEDURES FOR VISITS TO FACILITIES HOUSING OR TRANSPORTING DOMESTIC OR WILD ANIMALS
5.2.10.1 - Pre-Inspection Activities
5.2.10.2 - General Inspection Procedures
5.2.10.3 - Special Situation Precautions
5.3 - EVIDENCE DEVELOPMENT
5.3.1 - TECHNIQUES
5.3.2 - FACTORY SAMPLES
5.3.3 - EXHIBITS
5.3.4 - PHOTOGRAPHS
5.3.4.1 - In-Plant Photographs
5.3.4.2 - Photo Identification and Submission
5.3.4.2.1 - Prints
5.3.4.2.2 - Color Slide Identification
5.3.4.2.3 - Negative Identification
5.3.4.2.4 - Video Recordings
5.3.4.2.5 - DIGITAL PHOTOGRAPHS OR VIDEO RECORDINGS
5.3.4.2.6 - GLOSSARY OF DIGITAL TERMINOLOGY
5.3.4.2.6.1 - Digital Data
5.3.4.2.6.2 - Analog Data
5.3.4.2.6.3 - Memory Card
5.3.4.2.6.4 - Original
5.3.4.2.6.5 - Original Copy
5.3.4.2.6.6 - Permanent Storage Media
5.3.4.2.6.7 - Time/Date Stamp
5.3.4.2.6.8 - Working Copy
5.3.4.3 - Preparing and Maintaining Digital Photographs as Regulatory Evidence
5.3.4.4 - Preparing Digital Photos for Insertion in a Turbo Establishment Inspection Report (EIR)
5.3.4.5 - Photograph Requests
5.3.5 - RECORDINGS
5.3.6 - RESPONSIBLE INDIVIDUALS
5.3.6.1 - Discussion on Duty, Power, Responsibility
5.3.6.2 - Inspection Techniques How to Document Responsibility
5.3.7 - GUARANTEES AND LABELING AGREEMENTS
5.3.7.1 - Guaranty
5.3.7.2 - Labeling Agreement
5.3.7.3 - Exemption Requirements
5.3.8 - RECORDS OBTAINED
5.3.8.1 - Identification of Records
5.3.8.2 - Identifying Original Paper Records
5.3.8.3 - Filmed or Electronic Records
5.3.8.3.1 - Microfilm/Microfiche and Electronic Information
5.3.8.3.2 - Electronic Information Received on CD-R, or other Electronic Storage Media
5.3.8.4 - Requesting and Working with Computerized Complaint and Failure Data
5.3.8.4.1 - Computerized Complaint and Failure Data
5.3.8.4.2 - Requesting Computerized Data
5.3.8.4.3 - Identification and Security of CD-R, Diskettes or Other Electronic Storage Media
5.3.8.4.4 - Data Integrity of Records Provided by Firm
5.3.8.4.5 - Electronic Information for Official Documentation
5.3.8.5 - Listing of Records
5.3.8.6 - Patient and/or Consumer Identification on Records
5.3.9 - REQUEST FOR SAMPLE COLLECTION
5.3.9.1 - FACTS Assignment Section
5.3.9.2 - FACTS Operations Section
5.3.9.3 - FACTS Organizations Section
5.3.10 - POST-INSPECTION NOTIFICATION LETTERS
5.4 - FOOD
5.4.1 - FOOD INSPECTIONS
5.4.1.1 - Preparation and References
5.4.1.2 - Inspectional Authority
5.4.1.2.1 - Written Demand for Records
5.4.1.2.2 - Written Request for Information
5.4.1.3 - Records Access Under BT Authority
5.4.1.4 - Food & Cosmetic Defense Inspectional Activities
5.4.1.4.1 - Food and Cosmetic Security
5.4.1.4.2 - Reconciliation Examinations
5.4.1.4.3 - Reconciliation Examination Guidance Part A
5.4.1.4.4 - Reconciliation Examination Guidance Part B
5.4.1.4.5 - Special Safety Precautions
5.4.1.5 - Food Registration
5.4.1.5.1 - Facilities Exempted from Registration
5.4.1.5.2 - Agency Website Link
5.4.1.5.3 - Inspectional Guidance
5.4.1.6 - CFSAN Bio-research Monitoring
5.4.2 - PERSONNEL
5.4.2.1 - Management
5.4.2.2 - Employees
5.4.3 - PLANTS AND GROUNDS
5.4.3.1 - Plant Construction, Design and Maintenance
5.4.3.2 - Waste Disposal
5.4.3.3 - Plant Services
5.4.4 - RAW MATERIALS
5.4.4.1 - Handling Procedure
5.4.4.2 - Condition
5.4.4.3 - Food Chemicals Codex
5.4.5 - EQUIPMENT AND UTENSILS
5.4.5.1 - Filtering Systems
5.4.5.2 - Sanitation of Machinery
5.4.5.3 - Conveyor Belt Conditions
5.4.5.4 - Utensils
5.4.5.5 - Mercury and Glass Contamination
5.4.5.6 - UV Lamps
5.4.5.7 - Chlorine Solution Pipes
5.4.5.8 - Sanitizing Practices
5.4.6 - MANUFACTURING PROCESS
5.4.6.1 - Ingredient Handling
5.4.6.2 - Formulas
5.4.6.3 - Food Additives
5.4.6.4 - Color Additives
5.4.6.5 - Quality Control
5.4.6.5.1 - Inspection System
5.4.6.5.2 - Laboratory Tests
5.4.6.5.3 - Manufacturing Code System
5.4.6.6 - Packaging and Labeling
5.4.6.6.1 - Quantity of Contents
5.4.6.6.2 - Labeling
5.4.6.6.3 - Nutritional Labeling
5.4.7 - SANITATION
5.4.7.1 - Routes of Contamination
5.4.7.1.1 - Insects
5.4.7.1.2 - Rodents
5.4.7.1.3 - Pesticides
5.4.7.1.4 - Other
5.4.7.2 - Microbiological Concerns
5.4.7.2.1 - Processing Equipment
5.4.7.2.2 - Employee practices
5.4.7.3 - Storage
5.4.7.3.1 - Food Transport Vehicles
5.4.7.3.2 - Vehicles at Receivers
5.4.7.3.3 - Vehicles at Shippers
5.4.8 - DISTRIBUTION
5.4.8.1 - Promotion and Advertising
5.4.8.2 - Recall Procedure
5.4.8.3 - Complaint Files
5.4.9 - OTHER GOVERNMENT INSPECTION
5.4.9.1 - Federal
5.4.9.2 - State and Local
5.4.9.3 - Grade A Dairy Plant Inspections
5.4.10 - FOOD STANDARDS
5.4.10.1 - Food Establishment Inspection
5.4.10.2 - Food Inspection Report
5.4.10.2.1 - Establishment Inspection Record (EI Record)
5.4.10.2.2 - Body of Report
5.4.10.2.3 - Special Information Section
5.4.10.3 - Violative Inspections
5.5 - DRUGS
5.5.1 - DRUG INSPECTIONS
5.5.1.1 - Preparation and References
5.5.1.2 - Inspectional Approach
5.5.1.3 - CDER Bio-research Monitoring
5.5.2 - DRUG REGISTRATION & LISTING
5.5.3 - PROMOTION AND ADVERTISING
5.5.4 - GUARANTEES AND LABELING AGREEMENTS
5.5.5 - OTHER INSPECTIONAL ISSUES
5.5.5.1 - Intended Use
5.5.5.2 - Drug Approval Status
5.5.5.3 - OTC Drugs
5.5.5.4 - Drug/Dietary Supplement Status
5.5.5.5 - Approved Drugs
5.5.5.6 - Investigational Drugs
5.5.5.7 - Clinical Investigators and/or Clinical Pharmacologists
5.5.6 - CDER BIO-RESEARCH MONITORING
5.5.7 - ADVERSE EVENT REPORTING
5.5.8 - DRUG INSPECTION REPORT
5.6 - DEVICES
5.6.1 - DEVICE INSPECTIONS
5.6.1.1 - Technical Assistance
5.6.1.2 - Sample Collection During Inspection
5.6.1.3 - Types of Inspections
5.6.1.4 - CDRH Bio-research Monitoring
5.6.2 - MEDICAL DEVICE QUALITY SYSTEM/GOOD MANUFACTURING PRACTICES
5.6.2.1 - Pre-Inspectional Activities
5.6.2.2 - High-Risk Devices - Subsection removed
5.6.2.3 - Quality Audit
5.6.2.4 - Records
5.6.2.5 - Complaint Files
5.6.3 - STERILE DEVICES
5.6.4 - LABELING
5.6.5 - GOVERNMENT-WIDE QUALITY ASSURANCE PROGRAM (GWQAP)
5.6.6 - CONTRACT FACILITIES
5.6.7 - SMALL MANUFACTURERS
5.6.8 - BANNED DEVICES
5.6.9 - DEVICE INSPECTION REPORTS
5.7 - BIOLOGICS
5.7.1 - DEFINITION
5.7.2 - BIOLOGICS INSPECTIONS
5.7.2.1 - Authority
5.7.2.1.1 - Blood Bank and Source Plasma Inspections
5.7.2.1.2 - Human Tissue Inspections
5.7.2.2 - Donor Confidentiality
5.7.2.3 - Inspectional Objectives
5.7.2.4 - Preparation
5.7.2.5 - Inspectional Approach
5.7.2.6 - Regulations, Guidelines, Recommendations
5.7.2.7 - Technical Assistance
5.7.2.8 - CBER Bio-research Monitoring
5.7.3 - REGISTRATION, LISTING AND LICENSING
5.7.3.1 - Registration and Listing
5.7.3.1.1 - Transfusion Services
5.7.3.1.2 - HCT/Ps
5.7.3.1.3 - Laboratories
5.7.3.1.4 - Military Blood Banks
5.7.3.2 - MOU's
5.7.3.3 - Biological License
5.7.3.4 - Approval of Biological Devices
5.7.4 - RESPONSIBLE INDIVIDUALS
5.7.5 - TESTING LABORATORIES
5.7.6 - BROKERS
5.8 - PESTICIDES
5.8.1 - PESTICIDE INSPECTIONS
5.8.2 - CURRENT PRACTICES
5.8.3 - GROWERS
5.8.3.1 - Pesticide Application
5.8.3.2 - Pesticide Misuse/Drift/Soil Contamination
5.8.4 - PACKERS AND SHIPPERS
5.8.5 - PESTICIDE SUPPLIERS
5.8.6 - PESTICIDE APPLICATORS
5.8.7 - SAMPLE COLLECTIONS
5.9 - VETERINARY MEDICINE
5.9.1 - CVM WEBSITE
5.9.2 - VETERINARY DRUG ACTIVITIES
5.9.3 - MEDICATED FEEDS AND TYPE A ARTICLES
5.9.4 - BSE ACTIVITIES
5.9.5 - TISSUE RESIDUES
5.9.6 - VETERINARY DEVICES
5.9.7 - ANIMAL GROOMING AIDS
5.9.8 - CVM BIO-RESEARCH MONITORING
5.10 - REPORTING
5.10.1 - ESTABLISHMENT INSPECTION REPORT (EIR)
5.10.2 - ENDORSEMENT
5.10.2.1 - Compliance Achievement Reporting System (CARS)
5.10.2.1.1 - Reporting Criteria
5.10.2.1.2 - Data Elements
5.10.3 - FACTS ESTABLISHMENT INSPECTION RECORD (EI Record)
5.10.4 - NARRATIVE REPORT
5.10.4.1 - Non-Violative Establishments
5.10.4.2 - Violative Establishments
5.10.4.3 - Individual Narrative Headings
5.10.4.3.1 - STANDARD NARRATIVE REPORT
5.10.4.3.2 - Summary
5.10.4.3.3 - Administrative Data
5.10.4.3.4 - History
5.10.4.3.5 - Interstate (I.S.) Commerce
5.10.4.3.6 - Jurisdiction (Products Manufactured and/or Distributed)
5.10.4.3.7 - Individual Responsibility and Persons Interviewed
5.10.4.3.8 - Firm's Training Program
5.10.4.3.9 - Manufacturing/Design Operations
5.10.4.3.10 - Manufacturing Codes
5.10.4.3.11 - Complaints
5.10.4.3.12 - Recall Procedures
5.10.4.3.13 - Objectionable Conditions and Management's Response
5.10.4.3.13.1 - Supporting Evidence and Relevance
5.10.4.3.13.2 - Discussion with management
5.10.4.3.14 - Refusals
5.10.4.3.15 - General Discussion with Management
5.10.4.3.16 - Additional Information
5.10.4.3.17 - Samples Collected
5.10.4.3.18 - Voluntary Corrections
5.10.4.3.19 - Exhibits Collected
5.10.4.3.20 - Attachments
5.10.4.3.21 - Signature
5.10.5 - EXHIBITS
5.10.5.1 - Electronic information
5.10.6 - ADDENDUM TO EIR
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