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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Program 7348.810

SUBJECT:

SPONSORS, CONTRACT RESEARCH ORGANIZATIONS AND MONITORS

IMPLEMENTATION DATE

March 11, 2011

REVISION:

COMPLETION DATE

Continuing

DATA REPORTING

PRODUCT CODES

PROGRAM ASSIGNMENT CODES

FACTS does not require product codes for Bioresearch Monitoring Inspections

09810 Food Additives

 

41810 Biologics (Human Cellular, Tissue, and
Gene Therapies)

 

42810 Biologics (Blood and Blood Products)

 

45810 Biologics (Vaccines and Allergenic
Products)

 

48810 Human Drugs

 

68810 Animal Drugs

 

83810 Medical Devices

 

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, 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.