FDA EIR - Gateway Analytical, LLC. - April 14, 2021

A pre-approval inspection of Gateway Analytical, LLC, a contract testing laboratory in Gibsonia, PA, was conducted by the FDA from April 13-14, 2021. This two-day inspection, under Compliance Program 7346.832, focused on the firm's particulate matter testing for a New Drug Application (NDA), specifically utilizing USP <788> Method 2. Notably, no Form FDA-483, Inspectional Observations, was issued. However, a significant verbal discussion item concerned deficiencies in the method verification process for USP <788> Method 2. Inspectors observed that the firm's verification study did not meet the required six-sample preparation for precision, performing only three, as outlined in USP chapter <1226>. Additional concerns included a lack of clarity on the number of vials used for sample preparation during verification and inconsistencies in vial pooling for routine testing, which could introduce analytical bias. Furthermore, an initial verification study used fewer vials than recommended by USP <788> for small-volume parenterals. In response, Gateway Analytical, LLC committed to updating its test method to ensure consistent vial pooling and provided a letter detailing plans to implement steps to meet USP <1788> and <1788.2> guidelines for subvisible particle determination by September 2021. These commitments will be verified during the next inspection. An "APPROVAL" recommendation was communicated post-inspection.