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

Source: https://www.keypedia.com/records/483/swiss-american-cdmo-llc/c7c2d191-f377-4096-beed-695d2bc226b7

> FDA 483 for Swiss American CDMO, LLC on December 16, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Swiss American CDMO, LLC
- Inspection Date: 2024-12-16
- Product Type: device
- Office Name: Dallas District Office
- Summary: 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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## Related Officers

- [issuing_officer](https://www.keypedia.com/people/roy-baby/69a18ef5-167c-41eb-a57e-3d138a0820c2)
- [Elizabeth A. Krolczyk](https://www.keypedia.com/people/elizabeth-a-krolczyk/ecf57c43-b88d-4f84-962b-9067eaad4a7c)

Company: https://www.keypedia.com/companies/swiss-american-cdmo-llc/a4a811fc-a442-480b-a003-b66ee374d059

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9