Inspections, Compliance, Enforcement, and Criminal Investigations


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This Chapter contains specific information on many types of investigations and each section provides additional guidance for you on how to investigate particular issues, special reporting requirements and where additional assistance can be obtained. Recall work, a special type of investigation, is covered in Chapter 7. There is an on-line training course in Investigations which covers many types of investigations and provides additional information.

An investigation is an information gathering activity you conduct for many different reasons. The purpose of any investigation is to determine and document facts concerning a particular issue so the Agency can make informed and sound decisions. Investigation is a general term and can apply to a very general activity or a specific type of information gathering process. Some specific types of investigations include a complaint investigation, a disaster investigation, a health fraud investigation and a product tampering investigation. Investigations can be distinguished from inspections because usually you will not need to issue an FDA 482, you will be working somewhere other than a manufacturing plant, you may be visiting retail establishments, consumers, or other government agencies. On rare occasions, you may be conducting an investigation without advising individuals you are a FDA employee. Keep in mind that investigations can not all be categorized and there will be times when you do issue an FDA 482, such as when you are at a manufacturing site or doing work similar to an inspection. Experience gained on the job will help you determine the proper course of action for these special situations.

Reporting an investigation is almost always done using a memorandum see Exhibit 5-17. The format is not as defined in sections as an inspection report. A good rule of thumb to follow is to first summarize what you did, why or give the reason for the investigation and briefly state the findings. After this, you can go into detail about how you conducted the investigation and what you found. Reporting the course of your investigation and your findings chronologically works in many situations. For long narratives, using headings will make it easier for the reader to follow your reporting. Some types of investigations have forms that need to be completed in addition to the narrative. Your report will be in English, see IOM 1.1.

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