PATH – FDA EIR, Jul 19, 2013

The U.S. Food and Drug Administration (FDA) conducted a surveillance inspection of Tox Path Specialists, LLC, a nonclinical laboratory located in Frederick, MD, from July 15 to July 19, 2013. The inspection was carried out under the regulatory framework for nonclinical laboratories involved in human and animal drug development.

During the inspection, the FDA identified observations of objectionable conditions or practices, which were formally documented and communicated to the company via a Form FDA 483. The inspection concluded with a "Voluntary Action Indicated" (VAI) classification. This classification indicates that, while observations were made that require attention, they did not warrant immediate official regulatory enforcement action. The firm is expected to voluntarily implement corrective actions to address these identified issues.

Tox Path Specialists, LLC submitted responses to the FDA 483, which were pending final review by the FDA's Center for Drug Evaluation and Research (CDER). A re-inspection was provisionally scheduled for December 13, 2013, to assess the effectiveness of the implemented corrective measures. The overall outcome emphasized the need for the firm to demonstrate sustained compliance to fully resolve the noted observations.