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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Inspections

Ch 3. Establishment Inspections

Chapter 3 Establishment Inspections

Table of Contents

 

 

Subchapter 300 GENERAL Pg 52
301 AUTHORITY
302 INTERNATIONAL ESTABLISHMENT INSPECTION
    302.1 Coverage
    302.2 Signing Non-FDA Documents
    302.3 Team Inspections
303 PRECAUTIONS
    303.1 Protective Devices
    303.2 Eyes and Ears
    303.3 Extremities
    303.4 Protective Clothing
    303.5 Respirators
304 LABEL REVIEW

Subchapter 310 MANAGEMENT RELATIONS Pg 54
    310.1 General
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 320 EVIDENCE DEVELOPMENT Pg 56
    320.1 Techniques
321 FACTORY SAMPLES
322 EXHIBITS
323 PHOTOCOPIES AND PHOTOGRAPHS
324 RECORDINGS
325 RESPONSIBLE INDIVIDUALS
326 GUARANTEES AND LABELING AGREEMENTS
327 DISTRIBUTION AND DOMESTIC FOLLOW-UP

Subchapter 330 FOOD Pg 56
    330.1 General
    330.2 Preparation and References
    330.3 Authority
    330.4 Authority to Obtain Records and Information in LACF and Acidified Food Plants
    330.5 Procedures

Subchapter 340
    340.1 General
341 DRUG REGISTRATION AND LISTING
342 PROCEDURE
343 DISTRIBUTION AND DOMESTIC FOLLOW UP
344 CONTRACT FACILITIES

Subchapter 350 DEVICES Pg 57
    350.1 General
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

Subchapter 360 BIOLOGIC PRODUCTS Pg 61
361 BIOLOGIC REGISTRATION AND LISTING
362 PROCEDURE

Subchapter 370 BIORESEARCH Pg 61

Subchapter 380 INSPECTION REPORTING
    380.1 General
    380.2 Responsibility
381 FACTS COVERSHEET AND REPORTING
382 NARRATIVE REPORT
    382.1 Non-violative Establishments
    382.2 Violative Establishments
    382.3 Individual Captions and other Information for the EIR
383 REPORT PROCESSING
384 DATA REPORTING IN FACTS
385 RESPONSIBILITY
386 INSPECTIONAL REFERENCES

Subchapter 390 SAMPLING Pg 61
    390.1 SAMPLE COLLECTION FOR PREAPPROVAL INSPECTIONS
    390.2 RECEIPT FOR SAMPLES
    390.3 PAYMENT OF SAMPLES
391 SHIPMENT OF SAMPLES

 

CHAPTER 3 EXHIBITS
Exhibit 1: FDA-483 Inspectional Observations Policy (PDF, , 70kb) Pg 66