# FDA 483 - Swiss American CDMO, LLC - December 19, 2022

Source: https://www.keypedia.com/records/483/swiss-american-cdmo-llc/b90e1262-f76b-4f55-a5a8-e8db140a8545

> FDA 483 for Swiss American CDMO, LLC on December 19, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Swiss American CDMO, LLC
- Inspection Date: 2022-12-19
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Swiss American CDMO, LLC in Carrollton, TX, a contract manufacturer, was cited for multiple significant quality system deficiencies during an FDA inspection. Observations included inadequate software and process validation, failures in corrective and preventive action procedures, and insufficient supplier management. One observation regarding software validation was a repeat finding from a previous inspection, indicating persistent issues.

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## Related Officers

- [Terri E. Gibson](https://www.keypedia.com/people/terri-e-gibson/f1a80f95-a5c4-4cae-9a4b-e23f367770bb)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab