FDA 483 - SpecGx LLC - February 27, 2026

SpecGx, LLC in Greenville, IL, was inspected from February 24-27, 2026, and received one observation regarding the delegation of quality unit responsibilities for raw material release. The firm was cited for relying on Certificates of Analysis without performing identity testing for a raw material and for using an off-site Quality Assurance unit for release decisions on materials for the Greenville site. These practices indicate potential deficiencies in the firm's quality control over incoming materials.