Roche Molecular Systems, Inc. – FDA EIR, Feb 27, 2017

The Food and Drug Administration (FDA) conducted a pre-market data audit inspection of Roche Molecular Systems, Inc. at their Pleasanton, CA facility. The inspection commenced on February 22, 2017, and concluded on February 27, 2017. This high-priority inspection, assigned by the Division of Bioresearch Monitoring, Center for Devices and Radiological Health (CDRH), was specifically a data audit. It was carried out under Compliance Program Guidance Manual 7348.810, which pertains to Sponsors, Contract Research Organizations, and Monitors. The primary objective was to verify data supporting a Pre-Market Approval (PMA) application for a medical device, encompassing several clinical protocols. The scope of the inspection involved a thorough review of various source documents from clinical investigator sites submitted to the sponsor. This included scrutinizing sample identification outcomes, patient data, electronic data management practices, specimen identification, labeling, and accountability. Additionally, the FDA reviewed electronic Case Report Forms (eCRFs), assessed adherence to study protocols, verified blinding procedures, and confirmed Institutional Review Board (IRB) approvals for each study and site. The inspection also noted that the sponsor was not involved in the informed consent process and there were no adverse events reported. Crucially, the inspection did not identify any objectionable conditions, deficiencies, or non-compliance. Consequently, no FDA Form 483 (Inspectional Observations) was issued to Roche Molecular Systems, Inc., and the inspection was classified as "No Action Indicated" (NAI). This classification confirms that the firm was found to be in compliance with regulatory requirements relevant to the audit. No further regulatory actions were required from the company following this inspection, and a "Firm in Compliance Letter" was subsequently issued.