Juanita Versace

Juanita Versace takes a systemic approach to her audits, focusing on overall sterility controls and the processes related to sterilization methods, storage, and handling of raw materials. She values products' safety and sterility over pure regulatory adherence, seeking to identify any issues that may compromise patient safety either through contamination, poor sterility practices or adverse reactions. Versace also values the systematic approach to process improvement, often noting lack of trend analysis in adverse events and complaints.

FDA Investigator Juanita Versace has consistently focused on sterility and cross-contamination issues. She is thorough in her audits, checking raw materials handling and the implementation of proper sterilization methods. Versace also centers on the evaluation of adverse events trends, ensuring that any systemic issues are properly tracked and addressed.