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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
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