Inspections, Compliance, Enforcement, and Criminal Investigations

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.

Page Last Updated: 04/15/2015
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