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 |
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| COMPLETION DATE Continuing |
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| DATA REPORTING | ||
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PRODUCT CODES
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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.
