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Inspections, Compliance, Enforcement, and Criminal Investigations
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Exhibits
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CHAPTER 2 - EXHIBITS
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CHAPTER 3 - EXHIBITS
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CHAPTER 4 - EXHIBITS
- 4-1 FACTS SAMPLE COLLECTION SCREEN (5 pgs) (PDF - 372KB)
- 4-2 FACTS SAMPLE COLLECTION SCREEN (2 pgs) (PDF - 234KB)
- 4-3 AFFIDAVIT (IN-TRANSIT) - FDA 1664b (PDF - 309KB)
- 4-4 CARRIER'S RECEIPT FOR SAMPLE - FDA 472 (PDF - 296KB)
- 4-5 RECEIPT FOR SAMPLES - FDA 484 (2 pgs replace with 510C) (PDF - 355KB)
- 4-6 FIELD WEIGHT SHEET - FDA 485 (PDF - 410KB)
- 4-7 AFFIDAVIT - FDA 463a (PDF - 358KB)
- 4-8 COPY OF INVOICE/SHIPPING RECORD - FD1662 (PDF - 359KB)
- 4-9 AFFIDAVIT (PARCEL POST) - FDA 463 (PDF - 325KB)
- 4-10 AFFIDAVIT - FDA 463a (PDF - 357KB)
- 4-11 AFFIDAVIT - FDA 463a (PDF - 369KB)
- 4-12 AFFIDAVIT - FDA 1664 (PDF - 325KB)
- 4-13 AFFIDAVIT - FDA 463a (PDF - 361KB)
- 4-14 AFFIDAVIT - FDA 1664a (PDF - 357KB)
- 4-15 FACTS SAMPLE COLLECTION SCREEN (PDF - 192KB)
- 4-16 FACTS SAMPLE COLLECTION SCREEN (PDF - 211KB)
- 4-17 OFFICIAL SEAL - FDA 415a (PDF - 365KB)
- 4-18 DECLARATION FOR DANGEROUS GOODS (PDF - 311KB)
- 4-19 DRY ICE STICKER (PDF - 266KB)
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CHAPTER 5 - EXHIBITS
- 5-1 FORM FDA 482 Notice of Inspection (2 pgs) (PDF - 384KB)
- 5-2 FDA 482a Demand for Records (PDF - 381KB)
- 5-3 FDA 482b Request for Information (PDF - 362KB)
- 5-4 MODIFIED FDA 482 (PDF - 351KB)
- 5-5 FORM FDA 483 (2 pgs) (PDF - 385KB)
- 5-6 INSERTING DIGITAL PHOTOS INTO TURBO EIR (Resize Photo) (PDF - 313KB)
- 5-7 INSERTING DIGITAL PHOTOS INTO TURBO EIR (Insert Photo) (PDF - 298KB)
- 5-8 INSERTING DIGITAL PHOTOS INTO TURBO EIR (Resize using MS Office Picture Manager) (PDF - 817KB)
- 5-9 FACTS Create Assignment Screen (1 pg) (PDF - 262KB)
- 5-10 FDA 482(c) Notice of Inspection Request for Records (PDF - 349KB)
- 5-11 FOOD ADDITIVES NOMOGRAPHS (PDF - 273KB)
- 5-12 SUMMARY OF REGISTRATION AND LISTING*** HUMAN PHARMACEUTICALS (1 pg) (PDF - 376KB)
- 5-13 SUBSTANTIALLY EQUIVALENT MEDICAL DEVICES (1 pg) (PDF - 362KB)
- 5-14 FACTS - PROFILE - COMSTAT (6 pgs) (PDF - 447KB)
- 5-15 COMPLIANCE ACHIEVEMENT REPORT (PDF - 280KB)
- 5-16 FACTS EI RECORD (3 pgs) (PDF - 325KB)
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CHAPTER 6 - EXHIBITS
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CHAPTER 7 - EXHIBITS
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CHAPTER 8 - EXHIBITS
- 8-1 FACTS ADVERSE EVENT QUESTIONNAIRE (PDF - 151KB)
- 8-2 FACTS CONSUMER COMPLAINT REPORT (PDF - 133KB)
- 8-3 FACTS CONSUMER COMPLAINT FOLLOW-UP REPORT (PDF - 120KB)
- 8-4 FACTS COSMETICS ADVERSE EVENT (PDF - 127KB)
- 8-5 FORM FDA-461 (PDF - 225KB)
- 8-6 CLASSIFICATION OF ILLNESSES ATTRIBUTABLE TO FOODS (PDF - 394KB)
- 8-7 FORM FDA-3042 (PDF - 227KB)
- 8-8 ATTACK RATE TABLE (PDF - 234KB)
- 8-9 EPIDEMIC CURVE (PDF - 427KB)
- 8-10 MEDWATCH FORM (PDF - 1074KB)
- 8-11 VACCINE ADVERSE EVENT REPORT SYSTEM (PDF - 585KB)
- 8-12 Natural Disaster Form FD - 2809 (PDF - 236KB)
- 8-13 FORM FDA-457 (PDF - 275KB)
- 8-14 FEDERAL ANTI-TAMPERING ACT (PDF - 151KB)
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