FDA 483 - Custom Analytics LLC - March 12, 2026

From March 9 to March 12, 2026, the FDA inspected Custom Analytics LLC, a contract analytical testing laboratory in Dalzell, South Carolina. The inspection identified three primary violations related to facility maintenance and quality control. First, the laboratory"s design fails to prevent contamination; investigators noted a lack of physical barriers between the lab and office areas, a door opening directly to the outdoors, and the presence of a dog in the adjacent office in violation of company policy. These issues risk introducing animal dander and environmental particles into sensitive testing areas. Second, the firm does not maintain sanitation logs to prove that laboratory floors are cleaned according to their established schedules. Finally, the laboratory failed to adequately investigate errors found in their equipment testing procedures. Specifically, an investigation into balance calibration issues lacked a documented root cause and failed to evaluate if previous test results were compromised by the faulty procedures. These observations were issued under the Federal Food, Drug, and Cosmetic Act. Custom Analytics LLC is required to respond to these findings by submitting a plan for corrective actions or documentation of improvements already made to ensure the facility meets federal safety and quality standards.