FDA 483 - SpecGx, LLC - September 18, 2023

SpecGX, LLC, a human drug manufacturer in St. Louis, MO, was cited with two observations during an FDA inspection. The firm failed to establish and follow procedures to prevent objectionable microorganisms in non-sterile drug products, including inadequate testing for Burkholderia cepacia complex. Additionally, the firm did not thoroughly review an unexplained discrepancy related to equipment residue, with the investigation lacking microbial and chemical contamination testing and proper documentation of corrective actions.