483
Swiss American CDMO, LLCSwiss American CDMO, LLC – FDA 483, Dec 16, 2024
Record Details
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.
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ID · c7c2d191-f377-4096-beed-695d2bc226b7
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