FDA EIR - OpAns, LLC - August 16, 2019

An FDA analytical Bioresearch Monitoring (BIMO) inspection of OpAns, LLC (Optimized Analytical Solutions) in Durham, NC, occurred from August 12-16, 2019. The inspection revealed significant concerns regarding bioanalytical operations. A Form FDA 483 was issued detailing three primary observations. First, OpAns analyzed and reported results from 23 dried blood spot (DBS) samples that analysts had documented as unsuitable due to "inconsistent and not accurate spots to punch," without noting these conditions in the final report. Second, three hemolyzed subject plasma samples were analyzed and reported without assessing the potential impact of hemolysis on analyte measurements. Third, 97 out of 98 plasma samples were stored for periods far exceeding the commercial ELISA kit's specified three-month limit (ranging from 95 to 817 days) without adequate long-term stability assessment. Additionally, the inspection highlighted that one DBS sample was analyzed beyond its established long-term stability, and a partial method validation for an analyte in cerebral spinal fluid (CSF) lacked assessments for specificity, benchtop, and processed sample stability. In response, OpAns acknowledged the findings and committed to conducting investigations, revising relevant Standard Operating Procedures (SOPs) to incorporate hemolysis assessments and comprehensive method validation for future immunoassays and studies, and implementing additional staff training.