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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Inspections

Guide to International Inspection and Travel

Guide to International Inspection and Travel

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

 

Subchapter 210 - TRAVEL Pg 29
    210.1 GENERAL
    210.2 OFFICIAL COMMUNICATIONS
211 COMMON CARRIER
    211.1 TRANSPORTATION PAYMENT
    211.2 RESPONSIBILITY
    211.3 RAIL
    211.4 AIR
    211.5 FREQUENT FLYER MILES
    211.6 AUTHORIZED REST STOP
    211.7 AUTO RENTAL
    211.8 TAXI AND OTHER PUBLIC CONVEYANCE (buses, subways, etc.)
    211.9 ACCIDENT INSURANCE
212 PER DIEM AND SUBSISTENCE
    212.1 RATES
    212.2 COMPUTATION
    212.3 ACTUAL EXPENSE PER DIEM
    212.4 HOSPITALIZED IN TRAVEL STATUS
213 ADVANCE OF FUNDS
    213.1 APPLICATION FOR ADVANCE OF FUNDS
214 TRAVEL ORDER/AMENDMENTS
215TRAVEL VOUCHERS
    215.1 PREPARATION OF TRAVEL VOUCHERS
    215.2 REIMBURSABLE EXPENSES
    215.3 SUPPLEMENTARY EXPENSES - TELEPHONE CALLS
216 ITINERARIES
217 PASSPORT/VISA

Subchapter 220 - LEAVE Pg 34
    220.1 GENERAL
    220.2 ANNUAL LEAVE
    220.3 SICK LEAVE
    220.4 COMPENSATORY TIME
    220.5 OVERTIME

Subchapter 230 - SAFETY/SECURITY Pg 35
    230.1 GENERAL
231 COUNTRIES WITH TRAVEL ALERTS
232 PERSONAL SAFETY
    232.1 TRAVEL DOCUMENTS
    232.2 HEALTH
    232.3 SECURITY CONSIDERATIONS WHEN TRAVELING ABROAD

Subchapter 240 - BUSINESS RELATIONS, ETHICS, CONDUCT AND SECURITY Pg 37
241 EQUIPMENT: CARE, CUSTODY, LOSS
242 OFFICIAL CREDENTIALS, BADGE
243 BUSINESS CARDS
244 EMPLOYEE CONDUCT
245 INTERACTION WITH OTHER GOVERNMENT OFFICIALS
246 IMPROMPTU SPEECHES

 

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

 

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