FDA 483 - Vital Care of Dickson, LLC - March 11, 2020

This FDA Form 483 document details observations from an inspection of a compounding facility. The facility is cited for two primary violations related to the quality and safety of its drug products, particularly those intended for intrathecal administration and Total Parenteral Nutrition (TPN).

Firstly, the firm is compounding with Active Pharmaceutical Ingredients (APIs) without verifying that they do not contribute objectionable endotoxin contamination. The Certificates of Analysis for the APIs used do not document endotoxin testing, and the firm has not performed any endotoxin testing on either the APIs or the finished sterile drug products, especially those for intrathecal administration. This indicates a failure to ensure the sterility and safety of injectable products.

Secondly, the firm has failed to conduct media fill studies that accurately simulate its aseptic processing operations under worst-case, most-challenging, and stressful conditions. Specifically, the compounding of TPN products involves several time-consuming aseptic manipulation steps. However, the current media fills are performed with only a few aseptic manipulation steps, which does not adequately represent the complexity and potential risks of their actual compounding processes. This suggests a deficiency in validating their aseptic manufacturing procedures, potentially compromising the sterility assurance of their compounded sterile products.