U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Inspection References
  4. Foreign Inspections
  5. Ch 3. Establishment Inspections
  1. Foreign Inspections

Ch 3. Establishment Inspections

Table of Contents

  • Subchapter 310 MANAGEMENT RELATIONS Pg 54
  • 311 NOTICE OF INSPECTION
  • 312 REPORTABLE OBSERVATIONS
    • 312.1 Non-reportable Observations
    • 312.2 FDA-483 Annotations
    • 312.3 Comstat/Contract Requirement Deficiencies
    • 312.4 Distribution of the Form FDA 483
  • 313 RECEIPT FOR SAMPLES
  • 314 REFUSALS
  • 315 DISCUSSION WITH MANAGEMENT
    • 315.1 Procedure for Discussion of Observations
    • 315.2 Protection of Privileged Information
    • 315.3 Freedom of Information (FOI) Act
  • 316 POST INSPECTION NOTIFIFCATON
  • 317 ESTABLISHMENT INSPECTION REPORT
  • Subchapter 350 DEVICES Pg 57
  • 351 DEVICE REGISTRATION AND LISTING
  • 352 PROCEDURE
  • 353 DISTRIBUTION AND DOMESTIC FOLLOW-UP
  • 354 CONTRACT FACILITIES
  • 355 INSPECTION INFORMATION
    • 355.1 Pre-inspection Activity
    • 355.2 510(K) Class III Devices
    • 355.3 PMA Devices
    • 355.4 Electronic Product Radiation Producing Devices
    • 355.5 High Risk Devices
    • 355.6 Designated Agent
  • 356 DOCUMENTATION
  • 357 DISCUSSION WITH MANAGEMENT
  • 358 REINSPECTION OF AUTOMATIC DETENTION FIRMS
  • 359 EXPEDITED REVIEW OF VIOLATIVE FINDINGS
  • CHAPTER 3 EXHIBITS
  • Exhibit 1: FDA-483 Inspectional Observations Policy (PDF, 70kb)
 
Back to Top