Gateway Analytical, LLC.March 20, 2026

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

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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.

Company: Gateway Analytical, LLC.
Inspection Date: March 20, 2026
Product Type: Drugs
Office: Philadelphia District Office
Person: Kara J. Wright

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ID · f7eb323d-00ce-44a3-95c7-94a24679639c