FDA 483 - ten23 health Valais AG - April 24, 2019

Swissfillon AG, a contract drug manufacturer in Visp, Switzerland, was cited for significant deficiencies in its aseptic processing areas. The inspection revealed inadequate environmental monitoring procedures, leading to microbial growth exceeding acceptance criteria, and a lack of proper cleaning and gowning instructions, resulting in observed improper aseptic techniques and potential product contamination.