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# FDA Inspection Cites SGS North America Contract Laboratory
- URL: https://www.fdaweb.com/fda-inspection-cites-sgs-north-america-contract-laboratory/
- Published: 2026-07-10T12:00:00.000Z
- Updated: 2026-09-14T13:42:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161440

An FDA inspection of SGS North America's contract testing laboratory identified significant concerns with the firm’s laboratory controls, including a failure to adequately verify reference standards used to test pharmaceutical products, according to a [Form 483](https://www.fda.gov/media/193529/download?ref=fdaweb.com) issued at the close of a March inspection.

The inspection was conducted 3/17-20 at the company's Lincolnshire, IL facility. FDA investigators issued a single observation, concluding that the laboratory's controls did not establish scientifically sound specifications, standards, sampling plans and test procedures needed to ensure that components and drug products conform to appropriate standards of identity, strength, quality and purity.

According to the Form 483, FDA found that SGS did not perform minimum verification testing to qualify reference standards used in the testing of drug products and raw materials for release and stability studies. Instead, the laboratory relied primarily on manufacturers' certificates of analysis (COAs) to assess the quality of incoming reference standards before use.

FDA cited the firm's internal procedure, *Reference Standards, Version 4 (SOP-000898)*, which instructs personnel to verify the purity and identification of reference standards through review of the accompanying COA rather than through independent analytical verification. Investigators documented multiple examples in which reference standards were used for analytical method transfers and other testing activities without documented testing to confirm their identity, quality or suitability before use.

The agency also identified additional instances in which reference standards from other suppliers were used in testing programs based solely on supplier documentation, rather than laboratory verification, according to the inspection report.