FDA 483 - SGS North America Inc. - March 20, 2026

From March 17 to March 20, 2026, the FDA conducted an inspection of SGS North America Inc., a contract laboratory located in Lincolnshire, Illinois. The resulting FDA Form 483 outlines a significant violation regarding the firm’s laboratory control systems. Specifically, the investigator observed that the laboratory failed to establish scientifically sound procedures to ensure drug products and raw materials conform to standards of identity, quality, and purity. The primary issue identified was the firm’s reliance on a supplier’s Certificate of Analysis (COA) for reference standards without performing independent verification testing. This failure to confirm the identity and suitability of reference standards occurred during critical operations, including method transfer studies and the release testing of various drug batches for assay, impurities, and dissolution. These standards are foundational to ensuring the accuracy of analytical results. The inspection was performed under the regulatory framework of Section 704(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act. While the observations do not constitute a final determination of non-compliance, the company is expected to respond to the FDA. Required actions include establishing robust verification protocols for all incoming reference standards, updating Standard Operating Procedures, and providing evidence of corrective measures to ensure future adherence to quality standards.