In 2011, Chris Wall, an HVAC technician at a Baxter Healthcare manufacturing site in North Carolina inspected the HEPA filters in a room where sterile Saline IV Bags were filled. He found them to be contaminated with mold. Management stopped him from changing them for 2 years, until he finally reached for help to the FDA. The result was a warning letter and 18 million dollar fine.
In this episode, Diane and I meet with Tony Lee of AT Analytical (http://www.atanalytical.com/) to discuss the 2013 incident of mold contamination, and how to prevent mold contamination and ensure customer safety.
