Inspections, Compliance, Enforcement, and Criminal Investigations
SUBCHAPTER 8.10 - GENERAL INVESTIGATION REPORTING
The current Field Accomplishment and Compliance Tracking System (FACTS) Investigation (Operation 13) is used to capture the findings, endorsement and accomplishment time for investigations. FACTS does not provide for the generation of a hard copy memorandum. Limitations on data input also inhibit your ability to produce an investigative memo describing all relevant facts of your investigation. Therefore, in each case where a hard copy is required, use the reporting method described below. The FACTS Summary and Endorsement should be annotated to indicate the location of the actual report and endorsement (i.e., "see KAN-DO files," "see FACTS Consumer Complaint #," etc.), along with minimal narrative text describing the findings of the investigation.
Following the completion of an investigation, you will prepare a written report in English (See IOM 1.1) of the investigation as directed by your supervisor, which documents all pertinent data, including referencing of firms and attachments/exhibits, samples collected, etc. Use memorandum format, with appropriate supervisory endorsement and routing. For consumer complaints complete the FACTS Complaint Follow-Up Report. See IOM 8.2, 8.2.8 and 8.4.5. For surveillance activities, use Surveillance Report form (FDA 457). See IOM 8.6.2. In other situations, use methods directed by your District.
In those instances where FACTS is used for simple data/time entry under the Investigation Operation, and when you may not need a written report (examples: OEI improvement or pesticide surveillance), then enter sufficient information in the appropriate FACTS fields. The fields are those necessary for your supervisor to endorse the entry.
FACTS Operation 13, Investigation, will be used for inspections where the firm is Out of Business (OOB), Not Official Establishment Inventory (NOEI), or where no inspection was made (i.e., when lack of FDA jurisdiction has been established). Currently, this requires a written, hard copy memorandum and supervisory endorsement for inclusion in your District's files. In the case of OOB and NOEI, this is required for the appropriate filing personnel to know to remove the active files and send to the record center or storage per District procedure. For "no inspection made" the information in the file, especially the reason, may be helpful to future investigators. When you have a FACTS assignment to conduct an inspection and you determine the firm is OOB or that there is no FDA jurisdiction (i.e., when no clinical research has been conducted by a clinical investigator), follow FACTS procedures for converting the operation 12 to an operation 13.
(For investigations involving the Import Process, see Chapter 6.1.2)