PATH – FDA EIR, May 11, 2017

An FDA establishment inspection was conducted at Tox Path Specialists, LLC, located in Frederick, MD, spanning from May 10, 2017, to May 11, 2017. The primary objective of this surveillance inspection, performed under the Food and Drug Administration's Bioresearch Monitoring (BIMOE) program and overseen by the Office of Scientific Investigations (CDER-OSIS), was to assess the company's compliance as a Nonclinical Laboratory. The scope of the inspection covered activities related to Human and Animal Drugs, acknowledging the firm's registration as a Sponsor-Investigator. The inspection concluded with a "No Action Indicated" (NAI) determination. This outcome signifies that the FDA investigator identified no significant objectionable conditions, deviations, or violations of regulatory requirements during the review of the firm's operations. Importantly, an FDA Form 483, which is typically issued to document observed deficiencies, was not deemed necessary for Tox Path Specialists, LLC. This positive conclusion reflects the company's adherence to applicable regulations. As a result, no specific violations or issues were cited, and therefore, no immediate corrective actions or further regulatory requirements were mandated by the FDA following this inspection. The district decision, confirming the NAI status, was finalized in June 2017, indicating the satisfactory state of the facility's compliance.