FDA 483 - WES Pharma Inc. - November 21, 2023

An FDA inspection of WES Pharma Inc., a human drug manufacturer in Westminster, MD, revealed two significant observations. The firm was cited for using inappropriate equipment design, specifically tape on a multiuse blender, and for failing to follow quality control unit procedures, including inadequate labeling of controlled substances and untimely closure of deviation investigations. These findings indicate deficiencies in maintaining proper manufacturing and quality systems.