FDA 483 - SpecGx LLC - October 22, 2025

SpecGx LLC in St. Louis, MO, was inspected from October 14-22, 2025, and received two observations. The inspection revealed deficiencies related to the establishment of appropriate specifications for APIs, specifically the lack of testing for Burkholderia cepacia complex, and inadequate monitoring of processed water used in manufacturing. These issues indicate potential concerns with product quality and manufacturing control.