INDEX INVESTIGATIONS OPERATIONS MANUAL …

1 INDEX INVESTIGATIONS OPERATIONS MANUAL 2020 INDEX 301(K) Sample .. Aflatoxin Sample Schedule .. Smpl Schdl 6 301(K) Samples .. After the Detention .. 702(b) Portion Collected .. After the fact travel order .. 702(b) Requirement .. Agency for Toxic Substances and Disease 703 Record Requests .. Registry .. Agreements .. 704(d) Sample .. Agricultural Marketing Service .. Air Travel .. -A- Alcohol and Tobacco Tax & Trade Bureau (TTB) .. Allergen Abandonment .. Allergen Samples Schedule .. Smpl Schdl 13 Abbreviated New Animal Drug Application American Goods Returned .. (ANADA) .. Ammonia Leaks .. Abbreviated New Drug Application (ANDA).

2 Anabolic Steroids Control Act of 1990 .. Abnormal Containers .. Analytical Assignment .. Access .. Analyzing Data/Hypothesis Formulation .. Accident Insurance .. Animal Feed .. Accidents .. Feed Sampling Chart .. Smpl Schdl 11 Federal Driver's Act .. Medicated Feed Sampling Chart .. Smpl Schdl 12 Federal Employee's Compensation Act .. Animal Grooming Aids .. GFV .. Liability .. Animal Origin Products .. POV .. Animal Plant Health Inspection Service .. Reports .. Annotation of the FDA 483 .. Accomplishment Hours .. Anonymity .. Acronyms .. Antibiotic .. Addendum to EIR .. Anti-tampering Act .. Exhibit 8-14 Additional (Add).

3 Application .. Additional Case History Interviews .. Application for Authorization to Relabel or Additional Information .. Perform Other Acts .. Additional Personnel .. Exhibit 6-2 Additional Sample .. Approved Drugs .. Address, Change of .. Aseptic Sample .. Address Information Request Letter .. Exhibit 3-3 Asphyxiation Hazards .. Address Labels .. Assistance .. Administration for Children .. Assignments (Interdistrict) .. Administrative Data .. Issuance Authority .. Adulteration .. Procedures .. Assignments & Reporting .. Advance of Funds Creating in FACTS .. Exhibit 5-9 ATM .. NSD and Assignments .. Authorization.

4 Assistance .. Adverse Event Reporting/Risk Evaluation and Mitigation Associate Commissioner for Regulatory Affairs .. Strategies (REMS) .. ATSDR .. Complaints .. Attachments .. FACTS Questionnaire .. Exhibit 8-1 Attack Rate Table .. Advice or Rights .. Exhibit 2-1 Attempted Bribery .. Affidavit Attire .. Import Investigation .. Exhibit 6-5 Attitude .. In-Transit Sampling .. Audit Check .. Audit/Certification .. [FDA1664b] .. Exhibit 4-3 Audit/Certification Sample .. Informant .. AUTHORITY .. Dealer [FDA 1664] .. Authority .. Exhibit 4-12 Authority .. FDA 463a .. Authority & Responsibility.

5 Exhibit 4-7 Authority for Examinations and INVESTIGATIONS .. Exhibit 4-10 Authority to Enter and Inspect .. Exhibit 4-11 Authority to Enter and Inspect .. Exhibit 4-13 Authority to Implement Section 702(E)(5) of .. Exhibit 6-5 FD&C Act .. Jobber [FDA 1664a] .. Auto Rental .. Exhibit 4-14 Auto Safety .. Parcel Post .. Exhibit 4-9 Warehouse [FDA 1664] .. -B- .. Exhibit 4-12 INVESTIGATIONS OPERATIONS MANUAL 2020 INDEX Bacteriological Business Cards .. Banned Devices .. Business Premises .. Basic Premises .. Bill of Lading .. -C- Biological Product .. Biological Products Calendar (Perpetual Julian).

6 Appendix B Licensed .. Candling .. Biologic License .. Canned & Acidified Food Sample Chart .. Smpl Schdl 2 Biological Samples .. Canned Fruit Sample Chart .. Smpl Schdl 7 Biologicals .. Capital Improvements .. Car rental .. Biologics Injury, Reaction or Fatality .. Carbadox Sample .. Biologics Inspection .. Care & Custody of Vehicles .. Approach .. Carrier In-Transit Sampling .. Authority .. Carrier Name .. Blood and Source Plasma Inspections .. Carriers/In-Transit Lots .. Brokers .. Carrier s Receipt for Sample FDA 472 .. Exhibit 4-4 Core Team .. Cash Payment .. Donor Confidentiality .. Guidelines .. Causes.

7 Human Tissue Inspections .. Cautions .. Inspectional Objectives .. CBER Bio Research Monitoring .. Licensing .. CDER Bio Research Monitoring .. Listing .. CDRH Bio Research Monitoring .. Preparation .. Center for Biologics Evaluation and Research .. Recommendations .. Registration .. Cell Phone .. Regulations .. Center for Devices and Radiological Health Responsible Person .. (CDRH) .. Team Biologics .. Technical Assistance .. Center for Drug Evaluation & Research (CDER) .. Testing Laboratories .. Division of Pharmaceutical Analysis (DPA) .. Bio-research Monitoring - CBER .. Center for Food Safety & Applied Nutrition Bio-research Monitoring - CFSAN.

8 (CFSAN) .. Bio-research Monitoring - CVM .. Bio-research Monitoring - CDER .. Center for Tobacco Products .. Bio-research Monitoring - CDRH .. Biosecurity Procedure Center for Veterinary Medicine .. Animal Grower .. Animal Husbandry .. Centers for Disease Control & Prevention (CDC) .. Animal Producer .. Certification .. 1 Inspection Procedure .. Certified and First Class Mail .. Pre-inspection Activities .. CFSAN Bio Research Monitoring .. Preparation .. Change of Address Information .. Special Situation .. Change of Official Station .. Bio-terrorism .. Charges for Supervision FDA 790 .. Bioterrorism Act.

9 Exhibit 6-3 Import Requirements under the BT Act .. Chemical .. Bird Contamination .. Chemical Contamination .. Collecting Exhibits and/or Subsamples .. Chemical Hazards .. Examination/Documentation of Contamination .. Chemical Spills .. Summary of Sample for Evidence .. Chlorine Solution Pipes .. Blackberry .. Citation (Cite) .. Blood and Blood Products Inspection .. Civil Number .. Blood Values .. Appendix C Claimant & Options .. Body of Report .. Claims for Reimbursement Bond Action Documentation .. Application for Relief .. Leave Taken In-Travel Status .. Conditional Release .. Personal Laundry .. Notice of Refusal.

10 Receipts .. Bonded Warehouse .. Reimbursable Expenses .. Borrowed Samples .. Telephone Expenses .. Brand Name .. Travel voucher .. Break Bulk Cargo .. Class I .. Bribery .. Class I Recall .. Broken Official Seals and "Temporary Seals" .. Class II .. Class II Recall .. BSE Activities .. Class III .. Bulk Shipments .. Class III Recall .. INDEX INVESTIGATIONS OPERATIONS MANUAL 2020 Classification of Devices .. Exhibit 5-15 Clinical Investigators and/ or Clinical Compliance Achievement Reporting System Pharmacologists .. (CARS) .. Closeout Inspection .. Computerized Complaint and Failure Clothing.