FDA 483 - Argenta US Manufacturing LLC - August 01, 2019

An FDA inspection of Bayer Healthcare US, LLC. in Shawnee, KS, revealed two significant deficiencies. The firm failed to adequately retest active pharmaceutical ingredients after extending their retest dates without scientific justification. Additionally, the aseptic processing areas were found to have cracked panel doors, compromising the cleanability and integrity of the sterile environment.