FDA 483 - Mixlab TX LLC - August 02, 2024

From July 23, 2024, to August 2, 2024, the FDA inspected Mixlab TX LLC, a producer of sterile and non-sterile drug products in Weatherford, TX. The inspection, led by Margaret M Annes and Stephanie M Mongeluzzi, identified eight observations regarding the firm's quality control, manufacturing, and testing procedures.

Key observations include: 1. **Quality Control Unit Deficiencies:** The firm lacks written procedures for the Quality Unit's responsibilities, including drug product release/rejection. Sterile drug products are released before final sterility test results are received, and there's no documented review/approval by the quality control unit. 2. **Sterilization and Aseptic Process Validation:** Sterilization cycles for injectable drug products are not validated. Media fills do not simulate actual production conditions or cover worst-case scenarios, and documentation for media fills is incomplete. 3. **Environmental Monitoring Deficiencies:** Environmental and personnel monitoring in classified areas (ISO 5/ISO 7) is not performed daily during sterile drug production. Monitoring is not conducted during media fills. 4. **Container/Closure Processing Validation:** Cleaning, sterilization, and depyrogenation processes for stoppers, vials, and filling equipment are not validated. There's no system to track re-sterilized components. 5. **Sterility and Endotoxin Testing:** Diclazur