FDA 483 - Gateway Analytical, LLC. - March 20, 2026

Gateway Analytical, LLC, a contract laboratory in Gibsonia, PA, was cited for failing to follow written procedures for the cleaning and maintenance of equipment. Specifically, a critical freezer used for storing analytical samples experienced multiple temperature excursions due to overdue preventative maintenance, without scientific justification. This indicates a significant lapse in maintaining controlled storage conditions for customer samples.