FDA EIR - Johns Hopkins University Laboratory - June 14, 2019

An FDA inspection was conducted at Johns Hopkins University Laboratory in Baltimore, MD, from June 10-14, 2019. This for-cause inspection, conducted under the Good Laboratory Practice (GLP) regulatory framework (21 CFR Part 58), aimed to verify data quality and integrity for a non-clinical study supporting an Investigational Device Exemption (IDE) application, and to assess the laboratory's compliance with GLP regulations.

The inspection resulted in a four-item FDA-483 detailing significant observations. Main issues included deficiencies in device accountability, data integrity, and the study director's assurance of GLP conformance. A critical finding was the sponsor's failure, acting as Testing Facility Management, to ensure a Quality Assurance Unit fully compliant with GLP regulations, specifically regarding comprehensive on-site audits and an adequate QA plan. Furthermore, there was a widespread lack of documented formal GLP training for Johns Hopkins University personnel and other study participants. The facility also lacked appropriate standard operating procedures (SOPs) for various critical operations, including equipment validation, calibration, maintenance, and the handling and storage of test articles. Discrepancies in animal census records were also noted.

Management acknowledged the observations and committed to implementing corrections, providing a written response within 15 business days. The inspection highlighted the need for robust quality systems and strict adherence to GLP standards for studies supporting regulatory submissions.