FDA EIR - Andrew Blauvelt, MD, MBA - December 08, 2020

An FDA inspection of clinical investigator Andrew Blauvelt, MD, MBA, operating as Oregon Medical Research Center (OMRC) in Portland, OR, was conducted from November 30 to December 8, 2020. This surveillance inspection, part of a BLA and IND review, assessed compliance with Good Clinical Practice regulations (Compliance Program 7348.811).

While no Form FDA 483 (Inspectional Observations) was issued during this inspection, several discussion items were noted. These included the use of different assessors for primary efficacy endpoint data at baseline and week 16 for a significant number of subjects, contrary to protocol guidance emphasizing consistent assessment. Additionally, two instances of discrepancies between source documentation and electronic case report form data for adverse event severity and medical condition onset were identified. A sub-investigator's failure to timely sign a reconsent form for one subject was also noted, though later rectified. A dosing error affecting one subject due to an "IVRS programming issue" was reported by the sponsor and addressed. The site could not independently verify drug administration due to a lack of specific kit-to-drug documentation.

In response, Dr. Blauvelt committed to implementing policies to ensure consistent assessors for primary endpoint data in future studies and to enhance documentation accuracy. This inspection noted improvement as it did not repeat most issues from a prior 2015 inspection which had resulted in multiple 483 observations, including failures to follow the investigational plan and adequately document study drug.