FDA EIR - Smithers Pharmaceutical Development Services - December 13, 2024

An FDA surveillance inspection of Smithers Pharmaceutical Development Services, located in Gaithersburg, MD, was conducted from December 9 to December 13, 2024. This inspection, carried out under Compliance Program 7348.004 for In Vivo Bioavailability/Bioequivalence Studies (Analytical), was part of a Fiscal Year 2025 assignment focusing on bioanalytical activities supporting Biologics License and Investigational New Drug applications.

The inspection involved an analytical data audit and facility review, encompassing equipment maintenance, calibration records, freezer temperature logs, standard operating procedures (SOPs), and personnel training. At the conclusion of this inspection, no Form FDA-483 (Inspectional Observations) was issued. However, one discussion item was raised with management: the firm's failure to notify the shipper upon receipt of samples. Ms. Christina M. Satterwhite, President, acknowledged this observation and committed to addressing it with study staff.

A previous inspection in March 2019, when the firm operated as Avanza Bioanalytical Services LLC, also resulted in no FDA-483 but included several discussion points. These prior issues, which concerned an SOP deviation, vivarium findings (e.g., ice buildup), lack of approval for a specific document, formulation discrepancies, and non-compliant e-signatures, were noted as not recurring during the current inspection. The FDA classified the current inspection as "No Action Indicated," recommending no further follow-up at this time.