FDA EIR - Gateway Analytical, LLC. - September 16, 2022

An FDA surveillance inspection of Gateway Analytical, LLC, a contract control testing laboratory in Gibsonia, PA, was conducted from September 13-16, 2022. The inspection, carried out under Compliance Program 7356.002 for Drug Manufacturing Inspections, focused on the firm's Quality, Facilities & Equipment, Laboratory, and Materials Systems, and specifically assessed container closure integrity testing. Crucially, the inspection concluded with no significant observations or deficiencies, and no Form FDA 483, Inspectional Observations, was issued. This outcome signifies that the firm was found to be in a satisfactory state of compliance with regulatory requirements. The previous inspection in April 2021 also resulted in a "No Action Indicated" classification. The FDA investigator reviewed the firm's quality management system, including comprehensive procedures for out-of-specification investigations, corrective and preventative actions (CAPAs), and change control, all of which appeared well-managed. Facility conditions, equipment calibration, sample management, and the data integrity policy were also found to be robust. While the inspection identified no violations, the report noted the absence of written recall procedures. Management maintained full cooperation throughout the inspection.