FDA EIR - QPS, LLC - August 25, 2017

An FDA inspection of QPS, LLC in Newark, DE, was conducted from August 21-25, 2017. This Prescription Drug User Fee inspection, following Good Laboratory Practice (GLP) regulations outlined in Compliance Program Guidance Manual 7348.808, primarily aimed to verify corrective actions stemming from a previous June 2013 inspection. During the 2013 inspection, QPS, LLC received a Form FDA 483 citing deficiencies in documenting principal investigator-study director correspondence and issues related to the master schedule. A verbal observation also noted improper segregation of expired test compounds. The 2017 inspection confirmed that QPS, LLC had effectively implemented and maintained corrective actions for all previously identified issues. Enhanced documentation of communication between study personnel was verified, and processes for master schedule management were shown to be in place. Furthermore, improved procedures for segregating expired test compounds were confirmed. The inspection reviewed three specific studies to ensure compliance with GLP regulations, finding no new violations or issues. Consequently, no Form FDA 483 was issued, and no additional regulatory actions were required from QPS, LLC at the conclusion of this inspection, indicating a satisfactory resolution of prior findings.