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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CLINICAL INVESTIGATORS AND SPONSOR-INVESTIGATORS

 

PROGRAM 7348.811

CHAPTER 48- BIORESEARCH MONITORING

CLINICAL INVESTIGATORS AND SPONSOR-INVESTIGATORS

Date of Issuance:  December 8, 2008

Guidance for FDA Staff

SUBJECT: Clinical Investigators and Sponsor Investigators

REVISION:
IMPLEMENTATION DATE
December 8, 2008
COMPLETION DATE
Continuing
DATA REPORTING
PRODUCT CODES
PROGRAM ASSIGNMENT CODES
FACTS does not require product codes for Bioresearch Monitoring Inspections  09811 Food Additives
   41811 Biologics (Cell; Gene Transfer)
   42811 Biologics (Blood)
   45811 Biologics (Vaccines)
   48811 Human Drugs
   68811 Animal  Drugs
   83811 Medical Devices

 

FIELD REPORTING REQUIREMENTS:

For domestic inspections, copies of all establishment inspection reports (EIRs), complete with attachments, exhibits, and any related 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 FMD No. 86, Establishment Inspection Report (EIR) - Inspection Conclusions and District Decisions (http://www.fda.gov/ora/inspect_ref/fmd/fmd86.htm).  When a Form FDA 483, "Inspectional Observations" (483), is issued, a copy should be faxed to the Center contact, generally no later than 3 business days.