Swiss American CDMO, LLCDecember 16, 2024

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

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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.

Company: Swiss American CDMO, LLC
Inspection Date: December 16, 2024
Product Type: Device
Office: Dallas District Office
People: Roy Baby (issuing_officer)
Elizabeth A. Krolczyk

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ID · c7c2d191-f377-4096-beed-695d2bc226b7