FDA 483 - SpecGx, LLC - September 17, 2021

SpecGx, LLC in Webster Groves, MO, was cited for significant deficiencies across its drug product manufacturing operations. The inspection revealed issues with contamination control in weighing rooms, inadequate testing of water system components, and widespread failures in quality control procedures. Additionally, the facility exhibited poor equipment maintenance and unsanitary building conditions, including evidence of pest activity.