# FDA 483 - Swiss American CDMO, LLC - September 04, 2008

Source: https://www.keypedia.com/records/483/swiss-american-cdmo-llc/58282521-a4dc-475a-9560-92468189ec7a

> FDA 483 for Swiss American CDMO, LLC on September 04, 2008. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Swiss American CDMO, LLC
- Inspection Date: 2008-09-04
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Swiss American Products, Inc. in Carrollton, TX, a medical device manufacturer, revealed significant deficiencies in its quality system. The firm failed to establish and implement adequate design controls, process validation, document controls, and quality audit procedures for its Elta® Silver Gel Antimicrobial Wound Gel products. Additionally, issues were noted in equipment cleaning documentation and medical device reporting procedures.

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## Related Officers

- [Lauren E. Skokan, Biomed Eng.](https://www.keypedia.com/people/lauren-e-skokan-biomed-eng/92ab493a-3f91-43c2-9279-02f4f33ae812)
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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