FDA EIR - QPS, LLC - June 21, 2013

An FDA inspection of QPS, LLC, a nonclinical contract research organization in Newark, DE, was conducted from June 17-21, 2013. The inspection assessed the company's compliance with FDA Good Laboratory Practice (GLP) regulations (21 CFR Part 58) for nonclinical laboratories. A previous GLP inspection in 2010 had been classified as "Voluntary Action Indicated."

During the 2013 inspection, the FDA issued a Form FDA 483, outlining three primary observations. First, the testing facility's management did not ensure that all personnel clearly understood their assigned roles and responsibilities. Second, the company failed to retain all required documentation generated from nonclinical laboratory studies, specifically regarding correspondence and summaries of teleconferences with clients and study directors. Third, the Quality Assurance Unit did not maintain a complete and accurate master schedule sheet containing all necessary elements for all nonclinical studies conducted by the facility.

In response to these findings, QPS, LLC management committed to implementing corrective actions to address each observation. They also pledged to submit a formal written response to the FDA's 483 observations within 15 working days. The inspection also included verification of corrective actions previously taken in response to past inspection findings.