FDA EIR - Greenfield Pathology Services, Inc. - September 13, 2023

A routine, unannounced Good Laboratory Practice (GLP) inspection of Greenfield Pathology Services, Inc. (GPS) was conducted by the FDA from September 11-13, 2023, in Greenfield, IN. The inspection was initiated at the request of the Center for Drug Evaluation and Research (CDER) to assess the firm's adherence to GLP regulations for nonclinical laboratories, specifically Compliance Program 7348.808. The scope of the inspection included a thorough review of the facility, operational procedures, personnel qualifications, and general practices. Investigators also audited specific GLP studies where GPS provided pathology slide review services, such as intranasal, intramuscular, and topical ocular toxicity studies supporting Investigational New Drug (IND) applications. These studies involved various animal models. Crucially, the inspection concluded without any main violations or objectionable conditions being identified. No FDA Form 483, "Inspectional Observations," was issued to Greenfield Pathology Services, Inc., signifying that the firm was found to be in full compliance with the established regulatory framework. As a result, no specific required actions were necessitated, and no voluntary corrections were requested, reflecting a successful and compliant inspection outcome for the company.