FDA 483 - Radix Laboratories Inc - June 27, 2025

Radix Laboratories Inc. in Eau Claire, Wisconsin, was inspected and received a Form 483 with five observations primarily concerning significant deficiencies in quality control, batch record management, laboratory controls, and material handling. The inspection revealed failures in following established procedures for batch record approvals, contemporaneous record-keeping, raw data transfer, and proper storage and identification of raw materials. Additionally, the firm's annual product reviews were found to be incomplete and lacking proper quality control unit review.