FDA 483 - PMC Biogenix, Inc. - April 25, 2017

An FDA inspection of PMC Biogenix, an API manufacturer in Memphis, TN, revealed significant issues across three observations. The firm failed to validate the cleaning of truck trailers to prevent cross-contamination and exhibited deficiencies in its Quality Management Review process for Glycerin, USP. Additionally, equipment qualification was found to be inadequate, lacking demonstration of critical performance parameters.