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Subchapter 100 - GENERAL
101 STAFFING
102 LOCATION
Subchapter 110 - RESPONSIBILITIES
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
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
215 TRAVEL 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
220.1 GENERAL
220.2 ANNUAL LEAVE
220.3 SICK LEAVE
220.4 COMPENSATORY TIME
220.5 OVERTIME
Subchapter 230 - SAFETY/SECURITY
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
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
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
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
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
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
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
361 BIOLOGIC REGISTRATION AND LISTING
362 PROCEDURE
Subchapter 370 BIORESEARCH
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
390.1 SAMPLE COLLECTION
FOR PREAPPROVAL INSPECTIONS
390.2 RECEIPT FOR SAMPLES
390.3 PAYMENT OF SAMPLES
391 SHIPMENT OF SAMPLES
Subchapter 400 - GENERAL
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
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
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