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Chapter 5 - ESTABLISHMENT INSPECTION
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
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