Inspections, Compliance, Enforcement, and Criminal Investigations

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) Pg 66

Page Last Updated: 04/27/2015
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