FDA 483 - SpecGx LLC - February 27, 2026
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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.
- Office
- Chicago District Office
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ID · 1114cee7-20e5-4785-b5c5-5f8988e4a98c