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Investigation Operations Manual…

FDA Investigator's Guide

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
  © 2006 Betterchem Corp.

ESTABLISHMENT INSPECTION   [Chapter 5]

SUBCHAPTER 500 - INSPECTION INFORMATION
501 - AUTHORITY TO ENTER AND INSPECT
     501.01 - Business Premises
     501.02 - Premises Used for Living Quarters
     501.03 - Facilities where Electronic Products are Used or Held
     501.04 - Multiple Occupancy Inspections
     501.05 - Authority for Examinations and Investigations
     501.06 - Authority to Implement Section 702(e)(5) of the FD&C Act
     501.07 - Products Imported Under the Provisions of
     Section 801(d)(3) of the FD & C Act

502 - INSPECTIONAL APPROACH
     502.01 - Depth of Inspection
     502.02 - Signing Non-FDA Documents
     502.03 - Technical Assistance
     502.04 - Team Inspections
503 - INSPECTION OF FOREIGN FIRMS
504 - INSPECTIONAL PRECAUTIONS
     504.01 - Clothing
     504.02 - PHS Recommendations - Basic Sanitary Practices
     504.03 - Representatives Invited by the Firm to View the Inspection
SUBCHAPTER 505 - GENERAL PROCEDURES & TECHNIQUES
     505.01 - Candling
     505.02 - Label Review
     505.03 - Field Exams
SUBCHAPTER 510 - INSPECTION PROCEDURES
510 - PRE-INSPECTIONAL ACTIVITIES
     510.01 - Personal Safety
     510.02 - Personal Safety Alert
     510.03 - Situational Plan
511 - NOTICE OF INSPECTION
     511.01 - Multiple Date Inspections
     511.02 - Inspection of Vehicles
     511.03 - Follow-Up Inspections by Court Order
     511.04 - Conducting Regulatory Inspections When the Agency is
         Contemplating Taking, or is Taking, Criminal Action

     511.05 - When Evidence of a Criminal Violation is
         Discovered in the Course of a Regulatory Inspection

     511.06 - Use of Evidence Gathered in the Course of a Criminal Investigation
     511.07 - Use of Evidence Voluntarily Provided to the Agency
     511.08 - Concurrent Administrative, Civil, and Criminal Actions
     511.09 - Working with a Grand Jury
512 - REPORTS OF OBSERVATIONS
     512.01 - Reportable Observations
     512.02 - Non-Reportable Observations
     512.03 - Annotation of the FDA 483
     512.04 - Government Wide Quality Assurance Program (GWQAP)
     512.05 - Distribution of the FDA 483
513 - RECEIPT - FACTORY SAMPLES
     513.01 - Items Requiring Receipt
     513.02 - Items Not Requiring Receipt
514 - INSPECTION REFUSAL
     514.01 - Hostile and Uncooperative Interviewees
515 - INSPECTION WARRANT
516 - DISCUSSIONS WITH MANAGEMENT
     516.01 - Protection of Privileged Information
     516.02 - Refusals of Requested Information
517 - CONSUMER COMPLAINTS
518 - INTERVIEWING CONFIDENTIAL INFORMANTS
519 - ROUTINE BIOSECURITY PROCEDURES FOR VISITS TO FACILITIES
         HOUSING OR TRANSPORTING DOMESTIC OR WILD ANIMALS

     519.01 - Pre-Inspection Activities
     519.02 - General Inspection Procedures
     519.03 - Special Situation Precautions
SUBCHAPTER 520 - EVIDENCE DEVELOPMENT
520 - TECHNIQUES
521 - FACTORY SAMPLES
522 - EXHIBITS
523 - PHOTOGRAPHS - PHOTOCOPIES
     523.01 - In-Plant Photographs
     523.02 - Photo Identification and Submission
     523.021 - Preparing and Maintaining Digital Photographs as Regulatory Evidence
     523.03 - Photograph Requests
524 - RECORDINGS
525 - RESPONSIBLE INDIVIDUALS
     525.01 - Discussion on Duty, Power, Responsibility
     525.02 - Inspection Techniques How to Document Responsibility
526 - GUARANTEES AND LABELING AGREEMENTS
527 - RECORDS OBTAINED
     527.01 - Identification of Records
     527.02 - Identifying Original Paper Records
     527.03 - Filmed or Electronic Records
     527.04 - Requesting and Working with Computerized Complaint and Failure Data
     527.041 - Computerized Complaint and Failure Data
     527.042 - Requesting Computerized Data
     527.043 - Identification and Security of CD-R,
     Diskettes or Other Electronic Storage Media

     527.044 - Data Integrity of Records Provided by Firm
     527.045 - Electronic Information for Official Documentation
     527.05 - Listing of Records
     527.06 - Patient and/or Consumer Identification on Records
528 - REQUEST FOR SAMPLE COLLECTION
529 - POST-INSPECTION NOTIFICATION LETTERS
SUBCHAPTER 530 - FOOD
530 - FOOD INSPECTIONS
     530.01 - Preparation and References
     530.02 - Inspectional Authority
     530.03 - CFSAN Bio-research Monitoring
     530.04 - Food and Cosmetics Defense Inspectional Activities
     530.05 - Food Registration
531 - PERSONNEL
532 - PLANTS AND GROUNDS
533 - RAW MATERIALS
534 - EQUIPMENT AND UTENSILS
535 - MANUFACTURING PROCESS
     535.01 - Ingredient Handling
     535.02 - Formulas
     535.03 - Food Additives
     535.04 - Color Additives
     535.05 - Quality Control
     535.06 - Packaging and Labeling
536 - SANITATION
     536.01 - Routes of Contamination
     536.02 - Microbiological Concerns
     536.03 - Storage
537 - DISTRIBUTION
538 - OTHER GOVERNMENT INSPECTION
539 - FOOD STANDARDS
     539.01 - Food Establishment Inspection
     539.02 - Food Inspection Report
     539.03 - Violative Inspections
SUBCHAPTER 540 - DRUGS
540 - DRUG INSPECTIONS
     540.01 - Preparation and References
     540.02 - Inspectional Approach
     540.03 - CDER Bio-research Monitoring
541 - DRUG REGISTRATION & LISTING
542 - PROMOTION AND ADVERTISING
543 - GUARANTEES AND LABELING AGREEMENTS
544 - NEW DRUGS, ANTIBIOTICS, INVESTIGATIONAL DRUGS
     544.01 - Drug/Dietary Supplement Status
545 - CDER BIO-RESEARCH MONITORING
546 - Adverse Event Reporting
549 - DRUG INSPECTION REPORT
SUBCHAPTER 550 - DEVICES
550 - DEVICE INSPECTIONS
     550.01 - Technical Assistance
     550.02 - Sample Collection During Inspection
     550.03 - Types of Inspections
     550.04 - CDRH Bio-research Monitoring
551 - MEDICAL DEVICE QUALITY SYSTEM/GOOD MANUFACTURING PRACTICES
     551.01 - Pre-Inspectional Activities
     551.02 - High-Risk Devices
     551.03 - Quality Audit
     551.04 - Records
     551.05 - Complaint Files
     551.06 - In Vitro Diagnostics
552 - STERILE DEVICES
553 - LABELING
554 - GOVERNMENT-WIDE QUALITY ASSURANCE PROGRAM (GWQAP)
555 - CONTRACT FACILITIES
556 - SMALL MANUFACTURERS
557 - BANNED DEVICES
559 - DEVICE INSPECTION REPORTS
SUBCHAPTER 560 - BIOLOGICS
560 - DEFINITION
561 - BIOLOGICS INSPECTIONS
     561.01 - Preparation
     561.02 - Inspectional Approach
     561.03 - Regulations, Guidelines, Recommendations
     561.04 - Technical Assistance
     561.05 - CBER Bio-research Monitoring
562 - REGISTRATION, LISTING AND LICENSING
563 - RESPONSIBLE INDIVIDUALS
564 - TESTING LABORATORIES
565 - BROKERS
SUBCHAPTER 570 - PESTICIDES
570 - PESTICIDE INSPECTIONS
571 - CURRENT PRACTICES
572 - GROWERS
573 - PACKERS AND SHIPPERS
574 - PESTICIDE SUPPLIERS
575 - PESTICIDE APPLICATORS
576 - SAMPLE COLLECTIONS
SUBCHAPTER 580 - VETERINARY MEDICINE
580 - CVM WEBSITE
581 - VETERINARY DRUG ACTIVITIES
582 - MEDICATED FEEDS AND TYPE A ARTICLES
583 - BSE ACTIVITIES
584 - TISSUE RESIDUES
585 - VETERINARY DEVICES
586 - ANIMAL GROOMING AIDES
587 - CVM BIO-RESEARCH MONITORING
SUBCHAPTER 590 - REPORTING
590 - ESTABLISHMENT INSPECTION REPORT (EIR)
591 - ENDORSEMENT
     591.01 - Compliance Achievement Reporting System (CARS)
592 - FACTS ESTABLISHMENT INSPECTION RECORD (EI Record)
593 - NARRATIVE REPORT
     593.01 - Non-Violative Establishments
     593.02 - Violative Establishments
     593.03 - Individual Narrative Headings
594 - EXHIBITS
     594.01 - Electronic information
595 - ADDENDUM TO EIR