FDA EIR - Gateway Analytical, LLC. - January 15, 2015

The FDA conducted a pre-approval inspection of Gateway Analytical, LLC, a registered human pharmaceutical control laboratory located in Gibsonia, PA, on January 15, 2015. This inspection was carried out under the United States Food and Drug Administration's Compliance Program 7246.832, specifically for Pre-Approval Inspections.

During the inspection, the FDA evaluated the establishment's operations, which primarily involve criminal and pharmaceutical forensics. This includes identifying foreign particulates for pharmacovigilance programs and performing comparison testing for generic drug manufacturers. The firm also conducts analyses such as Inductively Coupled Plasma Mass Spectrometry (ICP-MS) for elemental impurities, a recognized USP methodology that could potentially support Abbreviated New Drug Applications (ANDAs). However, the company clarified that it does not perform human drug product release or stability testing.

The inspection included a thorough review of the company's internal quality program, its Laboratory Information Management System (LIMS) validation, the Quality Management System Manual, document control procedures, and sample management processes. Project-specific documentation, including contracts, purchase orders for subcontracted work, and analytical reports, were also examined.

Crucially, the inspection concluded without any significant findings or identified violations. Consequently, a Form FDA 483, which outlines inspectional observations requiring corrective actions, was not issued. This indicates that Gateway Analytical, LLC was operating in satisfactory compliance with the relevant regulatory framework at the time of the inspection, and no further actions were required from the company based on these findings.