FDA 483 - Swiss American CDMO, LLC - December 16, 2024

An FDA inspection of Swiss American CDMO, LLC in Carrollton, TX, a medical device manufacturer, revealed two significant observations. The firm failed to establish procedures for controlling nonconforming product, specifically regarding Burkholderia cepacia contamination in water used for manufacturing. Additionally, the compounding process for their wound dressing, EpiCeram, was not adequately validated, leading to numerous product consistency complaints.