FDA 483 - American Regent, Inc. - March 05, 2026

From March 2 to March 5, 2026, the Food and Drug Administration (FDA) inspected the American Regent, Inc. testing laboratory in Columbus, Ohio. The inspection identified two primary areas of concern regarding the facility"s quality management and investigative procedures. First, the Quality Control unit failed to follow and document established procedures for data review. This included a lack of verification for electronic raw data from critical equipment, such as high-performance liquid chromatography, and a failure to document the monitoring of expiration dates for laboratory reagents and standards. Second, the facility failed to thoroughly investigate instances where drug batches did not meet established specifications. The FDA noted that investigations into these out-of-specification results lacked clear documentation of initial laboratory assessments, failed to justify why certain batches were retested, and often omitted formal corrective and preventive actions or documented employee retraining. These observations were issued under the Federal Food, Drug, and Cosmetic (FD&C) Act. Although these findings do not constitute a final agency determination of compliance, the company is expected to respond to these observations by detailing their implemented or planned corrective actions to ensure laboratory practices meet regulatory standards for safety and quality.