Table of Contents

Subchapter 100 - GENERAL Pg 1

101 STAFFING

102 LOCATION

Subchapter 110 - RESPONSIBILITIES Pg 1

111 RECRUITMENT OF INTERNATIONAL INSPECTION CADRE MEMBERS

112 PLANNING INSPECTION TRIPS

112.1 INSPECTION REQUESTS

112.2 NUMBER AND TYPES OF FIRMS TO BE INSPECTED

112.3 LENGTH OF TRIP

112.4 TRIP LOCALE

112.5 SELECTION OF INVESTIGATOR/ ANALYSTS

112.6 FIRM/AGENT CONTACT

112.7 DISTRICT CONTACT

112.8 HEADQUARTERS COORDINATION

112.9 LABORATORY COORDINATION

113 TRIP FOLDER

113.1 ITINERARY

113.2 INTERNATIONAL ASSIGNMENT PLANNERS

113.3 PASSPORT/VISA

113.4 AIRLINE TICKETS

113.5 ADVANCE OF FUNDS

113.6 REFERENCE MATERIALS

114 BRIEFING

115 DEBRIEFING

116 TRAINING

117 NON-INSPECTIONAL REGULATORY TRAVEL

EXHIBITS

*This material is located in the FMD section of Inspection Reference, see FMD13 and FMD13A.

1-A International Inspections Program FMD 13 [PDF, 360kb]

Attachment A

Attachment B

Attachment C

Attachment D

Attachment E

Attachment F

1-B International Travel FMD 13A [PDF, 239kb]

Attachment A

Attachment B 

Subchapter 300 GENERAL Pg 52

301AUTHORITY

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 DRUGS

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) 

Subchapter 400 - GENERAL Pg 68

401 HEALTH CARE

401.1 Prophylaxis Measures

401.2 Personal Prescriptions

401.3 Shot Record

401.4 Emergencies

402 EMBASSIES/CONSULATES

403 OFFICE OF INTERNATIONAL AFFAIRS

404 BACKGROUND INFORMATION ON COUNTRIES

404.1 Country Profile

404.2 Background Notes

404.3 Health

404.4 Business and News

405 MONEY

405.1 Traveler's Checks

405.2 Currency

405.3 Tip Packets

405.4 Currency Exchange

405.5 Credit Cards

406 LODGING

407 TRAVEL TICKETS

408 ARRANGING TRAVEL WHILE ABROAD

409 LUGGAGE

Subchapter 410 - TRAVEL DOCUMENTS Pg 71

411 TRAVEL ADVISORIES

412 PER DIEM RATES

413 FOREIGN CULTURES AND MORES

414 U.S. CUSTOMS AND DUTY

415 PERSONAL SECURITY MEASURES

415.1 Money

415.2 Personal

415.3 Valuables 

EXHIBITS

4A Health Care Tips for International Travelers [PDF, 143kb] Pg 73

4B Security Considerations When Traveling Abroad [PDF, 59kb] Pg 80

4C List of U.S. Embassy and Consulate Offices [PDF, 260kb]Pg 82