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Inspection References
Investigations Operations Manual 2004
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Chapter 1 - EXHIBITS

EXHIBIT 110-B - ALLOWABLE EXPENSES CHART

EXHIBIT 110-D - TRAVEL VOUCHER (SF-1012) 

Chapter 3 - EXHIBITS

EXHIBIT 310-A - HISTORY OF MENU ITEMS

EXHIBIT 310-B - ADDRESS INFORMATION REQUEST (2 pgs)

EXHIBIT 311- FDA/USDA Jurisdiction Chart

Chapter 4 - EXHIBITS

EXHIBIT 410-A - CARRIER'S RECEIPT FOR SAMPLE - FDA 472

EXHIBIT 410-B - RECEIPT FOR SAMPLES - FDA 484

EXHIBIT 420-A - ANALYST WORKSHEET - FDA 431(2 pgs)

EXHIBIT 420-B - FIELD WEIGHT SHEET - FDA 485

EXHIBIT 430-A - COPY OF INVOICE/SHIPPING RECORD - FD1662

EXHIBIT 430-B - AFFIDAVIT (PARCEL POST) - FDA 463

EXHIBIT 430-C - AFFIDAVIT - FDA 463a

EXHIBIT 430-D - AFFIDAVIT - FDA 463a

EXHIBIT 430-E - AFFIDAVIT - FDA 1664

EXHIBIT 430-F - AFFIDAVIT - FDA 1664a

EXHIBIT 430-G - AFFIDAVIT - FDA 463a

EXHIBIT 430-H - FACTS SAMPLE COLLECTION SCREEN (2 pgs)

EXHIBIT 430-I1 - FACTS SAMPLE COLLECTION SCREEN (5 pgs)

EXHIBIT 430-I2 - FACTS SAMPLE COLLECTION SCREEN

EXHIBIT 430-I3 - FACTS SAMPLE COLLECTION SCREEN

EXHIBIT 430-I4 - FACTS SAMPLE COLLECTION SCREEN

EXHIBIT 430-I5 - FACTS SAMPLE COLLECTION SCREEN

EXHIBIT 430-J - FACTS SAMPLE COLLECTION SCREEN (2 pgs)

EXHIBIT 430-K - FACTS SAMPLE COLLECTION SCREEN

EXHIBIT 430-K2 - FACTS SAMPLE COLLECTION SCREEN

EXHIBIT 430-L - AFFIDAVIT (IN-TRANSIT) - FDA 1664b

EXHIBIT 430-M - AFFIDAVIT - FDA 463a

EXHIBIT 450-A - OFFICIAL SEAL - FDA 415a

EXHIBIT 450-B - DECLARATION FOR DANGEROUS GOODS

EXHIBIT 450-C - DRY ICE STICKER

Chapter 5 - EXHIBITS

EXHIBIT 510-A - FORM FDA 482 (2 pgs)

EXHIBIT 510-A1 - ATTACHMENT TO FDA 482 (1 pg)

EXHIBIT 510-A2 - MODIFIED FDA 482 (1 pg)

EXHIBIT 510-B - FORM FDA 483 (2 pgs)

EXHIBIT 510-C - FORM FDA 484 (2 pgs)

EXHIBIT 510-D - SAMPLE OF SITUATIONAL PLAN

EXHIBIT 530-B - FOOD ADDITIVES NOMOGRAPHS (2 pgs)

EXHIBIT 540 - SUMMARY OF REGISTRATION AND LISTING REQUIREMENTS FOR THE MANUFACTURE OR DISTRIBUTION OF HUMAN PHARMACEUTICALS

EXHIBIT 550 - SUMMARY OF REQUIREMENTS FOR THE MANFUFACTURE OR DISTRIBUTION OF SUBSTANTIALLY EQUIVALENT MEDICAL DEVICES

EXHIBIT 550-A - CBER - IVD REPORTING FORM (2pgs)

EXHIBIT 560 - IMPORTED BLOOD/BLOOD PRODUCTS REPORTING FORM

EXHIBIT 590-A - FACTS EI RECORD (3 pgs)

EXHIBIT 590-B - COMPLIANCE ACHIEVEMENT REPORT

EXHIBIT 590-C - FACTS - PROFILE - COMSTAT (6 pgs)

EXHIBIT 590-D - FACTS Create Assignment Screen (1 pg)

Chapter 6 - EXHIBITS

EXHIBIT 610-A - FORM FDA-766

EXHIBIT 610-B - CHARGES FOR SUPERVISION FORM FDA-790

EXHIBIT 610-C - NOTICE OF FDA ACTION

EXHIBIT 640-A - OASIS COLLECTION REPORT FORM

Chapter 7 - EXHIBITS

EXHIBIT 700-A - INTERROGATION; ADVICE OF RIGHTS

EXHIBIT 750-A - FORM FDA 2289

EXHIBIT 750-B - DETENTION TAG

EXHIBIT 750-C - FORM FDA 2291

Chapter 8 - EXHIBITS

EXHIBIT 810-A - RECALL COMMUNICATIONS - EXAMPLES

EXHIBIT 820-A - FORM FDA-3177, RECALL AUDIT CHECK REPORT

Chapter 9 - EXHIBITS

EXHIBIT 900-A - FACTS CONSUMER COMPLAINT REPORT

EXHIBIT 900-B - FACTS CONSUMER COMPLAINT FOLLOW-UP REPORT

EXHIBIT 900-C - FORM FDA-461

EXHIBIT 900-D - FACTS ADVERSE EVENT QUESTIONNAIRE

EXHIBIT 900-E - FACTS COSMETICS ADVERSE EVENT

EXHIBIT 910-A - ATTACK RATE TABLE

EXHIBIT 910-B - FORM FDA-3042

EXHIBIT 910-C - CLASSIFICATION OF ILLNESSES ATTRIBUTABLE TO FOODS

EXHIBIT 910-E - EPIDEMIC CURVE

EXHIBIT 920-A - MEDWATCH FORM

EXHIBIT 920-C - REPORTABLE EVENTS CHART & AIDS TO INTERPRETATION

EXHIBIT 920-D - VACCINE ADVERSE EVENT REPORT SYSTEM

EXHIBIT 960-A - FORM FDA-457

EXHIBIT 970-A - FEDERAL ANTI-TAMPERING ACT

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