FDA 483 - Mixlab TX LLC - July 24, 2025

Between July 14 and July 24, 2025, the FDA conducted an inspection of Mixlab WI LLC, a producer of non-sterile medications located in Milwaukee, Wisconsin. The resulting report identified several critical violations regarding the facility’s quality control and manufacturing processes. Key issues included staff failing to follow required protective clothing protocols and the improper handling of hazardous drugs in non-designated areas. Cleaning procedures were also found insufficient, as the firm used household-grade detergents instead of pharmaceutical-grade agents and failed to maintain proper cleaning logs or sanitize facility ceilings. Furthermore, the inspection noted significant deviations from production records, such as failing to protect light-sensitive ingredients and using incorrect mixing equipment. The facility did not perform routine potency testing on finished medications, nor did it verify the quality of ingredients received from suppliers. Documentation was consistently incomplete, lacking records for product inspections, filling volumes, and rejection reasons. Additionally, the firm lacked a scientific stability program to justify product expiration dates. These observations were issued under the Federal Food, Drug, and Cosmetic Act. While this report does not represent a final agency decision, Mixlab WI LLC is expected to respond by submitting a detailed corrective action plan. This plan must address how the company will rectify these safety and quality oversight failures to ensure compliance with federal standards.