SPONSORS, CONTRACT RESEARCH ORGANIZATIONS AND MONITORS
April 19, 2017
PROGRAM ASSIGNMENT CODES
FACTS does not require product codes for Bioresearch Monitoring Inspections
09810 Food Additives
41810 Biologics (Human Cellular, Tissue, and
42810 Biologics (Blood and Blood Products)
45810 Biologics (Vaccines and Allergenic
48810 Human Drugs
68810 Animal Drugs
83810 Medical Devices
98810 Tobacco Products
FIELD REPORTING REQUIREMENTS:
For domestic inspections, copies of all establishment inspection reports (EIRs), complete with attachments, exhibits, and any post-inspectional correspondence are to be submitted promptly to the Center contact, who is generally the reviewer in the Center’s Bioresearch Monitoring (BIMO) program identified in the assignment.
For foreign inspections, all original EIRs, complete with attachments, unlabeled exhibits and any related correspondence are to be submitted promptly to the Center contact identified in the assignment.
All EIRs should be completed in accordance with Field Management Directive (FMD) No. 86, Establishment Inspection Report (EIR) – Inspection Conclusions and District Decisions (http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm061430.htm). When a Form FDA 483, “Inspectional Observations” (483), is issued, a copy should be forwarded to the Center contact (by facsimile, e-mail, or placement in the appropriate shared folder, as agreed to with the Center), generally no later than 3 business days.
For both domestic and foreign inspections, a preliminary summary of findings should be submitted via email to the Center contact as soon as possible after the inspection has completed.