FDA EIR - OpAns, LLC - January 24, 2020

Optimized Analytical Solutions, LLC. (OpAns) underwent an FDA bioanalytical Bioresearch Monitoring (BIMO) inspection from January 21-24, 2020. This surveillance, conducted under Compliance Program 7348.004, focused on method validation and sample analysis for a specific investigational new drug (IND) study.The inspection identified several critical issues related to data integrity and laboratory practices. A consistent, unexplained peak was observed in chromatograms throughout method validation and sample analysis. Subsequent FDA investigation revealed this peak was an oxidation product of the primary analyte, indicating degradation. Furthermore, OpAns failed to store a key reference standard according to manufacturer recommendations in its Material Safety Data Sheet, exposing it to light, air, and moisture, which likely contributed to this degradation.The firm also neglected to cover light-sensitive study samples during processing at their facility, despite having contributed to a protocol that stipulated such precautions at clinical sites. Additionally, missing documentation for stock solution preparation and sample processing led to the reanalysis of multiple study samples, and a relevant laboratory notebook was reported lost. Notably, while these findings were detailed, the FDA did not issue a Form FDA 483 (Inspectional Observations) or specific immediate required actions at the inspection's conclusion.