FDA 483 - Meds For Vets - February 21, 2025

The FDA conducted an inspection of Meds For Vets, a producer of sterile and non-sterile drug products, located in Sandy, Utah, from February 11 to February 21, 2025. The inspection revealed several critical compliance issues under the regulatory framework governing drug manufacturing practices.

Key violations included inadequate procedures to prevent microbiological contamination, as the firm failed to validate aseptic and sterilization processes. Specifically, air pressure gauges essential for ensuring product sterility were uncalibrated, and sterilization cycles were neither qualified nor monitored with biological indicators. Additionally, visual inspections of sterile products were improperly conducted without adequate lighting or background, and there was no standard procedure for these inspections.

The firm also used non-pharmaceutical-grade ingredients in sterile drug production without scientific justification, compromising product safety. Containers and closures intended for sterile products were not properly sterilized or depyrogenated, and equipment used for sterilization, such as a countertop toaster oven, was not validated for its intended use.

Further observations included the absence of biological indicators to verify sterilization adequacy and improper aseptic practices by personnel, such as touching non-sterile surfaces and continuing aseptic processing without changing or sanitizing gloves.

The FDA requires Meds For Vets to address these deficiencies by implementing corrective actions, including validating sterilization processes, ensuring proper equipment calibration, and establishing robust procedures for aseptic operations. The firm must also justify the use of non-pharmaceutical ingredients and ensure all personnel adhere to aseptic protocols to maintain compliance with FDA regulations.