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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Compliance Program Guidance Manual - 7348.809

CHAPTER 48 – Bioresearch Monitoring
 

SUBJECT:
INSTITUTIONAL REVIEW BOARDS

IMPLEMENTATION

November 28, 2011

REVISION:

COMPLETION DATE

Continuing

DATA REPORTING

PRODUCT CODES

PROGRAM ASSIGNMENT CODES

FACTS does not require product codes for Bioresearch Monitoring Inspections

09809 (Food Additives)

 

41809 (Biologics-Human Cellular, Tissue, and Gene Transfer)

 

42809 (Biologics-Blood and Blood Products)

 

45809 (Biologics-Vaccines and Allergenic Products)

 

48809 (Human Drugs)

 

83809 (Medical Devices)

 

FIELD REPORTING REQUIREMENTS:

Copies of all establishment inspection reports (EIRs) complete with attachments, exhibits, and any related correspondence are to be submitted promptly to the Center (usually the reviewer in the Center’s Bioresearch Monitoring (BIMO) program identified in the assignment).

All EIRs should be completed in accordance with FMD No. 86, Establishment Inspection Report (EIR) - Inspection Conclusions and District Decisions(http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/UCM061430) and the Investigations Operation Manual (IOM), Chapter 5, Establishment Inspections. (http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM150576.pdf).  When a Form FDA 483, “Inspectional Observations” (483), is issued, a copy should be forwarded to the Center contact (by facsimile or e-mail, or filed in a shared folder, as agreed to with the Center), as soon as possible, generally within 3 business days after being issued.