FDA EIR - StageBio - August 12, 2019

An FDA surveillance inspection of StageBio, a nonclinical laboratory facility, was conducted from August 19 to August 21, 2019, at its Mason, Ohio location. The inspection, requested by the Center for Drug Evaluation and Research (CDER) and conducted under the PDUFA program, aimed to evaluate the company's compliance with 21 CFR Part 58 Good Laboratory Practice (GLP) regulations. StageBio provides GLP-compliant research and preclinical histology, pathology, and specimen archiving services for the biopharmaceutical, medical device, and contract research industries. The inspection reviewed the facility's operations, quality assurance unit, personnel, equipment, standard operating procedures (SOPs), and the performance of three nonclinical study protocols. Significantly, the current inspection concluded without the issuance of an FDA Form 483 (Inspectional Observations) or any new discussion items, indicating no objectionable conditions were found. This contrasts with a previous 2017 inspection that cited a Quality Assurance Unit deficiency. The company demonstrated voluntary corrections to previous observations, including improved document management, better study record organization, enhanced laboratory environment, and specific training for Principal Investigators regarding study oversight.