FDA Clears Up FEI Confusion

FDA Headquarters

A clinical study site network operator recently asked U.S. Food and Drug Administration (FDA) compliance experts for direction regarding FDA Establishment Identification (FEI) numbers. FEI is a unique identifier issued by the agency to track inspections of regulated establishments or facilities.

Specifically, the operator asked if all of its study sites can use the same FEI number for each inspection.

No, said David K. Glasgow, acting bioresearch monitoring deputy program director with the Office of Operations in FDA’s Office of Regulatory Affairs. 

“If the question [really] pertains to [inspection of] a clinical investigator (typically the physician responsible for conducting the study [at a site]), each clinical investigator inspected will receive a unique FEI,” he said.

The reason? “FEI pertains to [each investigator] as an inspected entity and would not change regardless of where they conducted the clinical investigation,” Glasgow said. For example, physicians may have privileges at multiple institutions and conduct multiple clinical investigations. However, an investigator’s FEI would always remain the same.

On the other hand, if the same question was asked in relation to inspection of a clinical testing facility for bioavailability/bioequivalence studies, the FEI is assigned to the facility, Glasgow added.

If an FDA 483 (Warning Letter) was issued at the close of the inspection, the FEI would be on that form. If no FDA 483 was issued, the inspected entity should have received a copy of the Establishment Inspection Report via an FDA procedure – Field Management Directive 145 (FMD 145), Glasgow said.

FDA to Offer 483 Response Tips at ACRP 2018 – Join FDA’s David Burrow at ACRP 2018 next month and take away practical approaches to working with FDA during an inspection, responding to 483s after an inspection, and responding to subsequent regulatory correspondence. This always-popular session will highlight recent inspection trends and identify key strategies to build quality into clinical research in order to prevent critical compliance issues. View Session Details

ACRP 2018

For routine inspections, when the inspection record has been closed by FDA and no action will be taken based upon the inspection conducted, a copy of the narrative report prepared by the investigator will be provided to the inspected entity. The FEI number would be printed on the narrative report.

“To obtain the FEI number [in that instance], you may ask the inspected entity,” Glasgow said.

Author: Michael Causey