# FDA 483 - Surmasis Pharmaceutical, LLC - August 01, 2025

Source: https://www.keypedia.com/records/483/surmasis-pharmaceutical-llc/a9754776-fa7b-407d-9e77-3850f1791576

> FDA 483 for Surmasis Pharmaceutical, LLC on August 01, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Surmasis Pharmaceutical, LLC
- Inspection Date: 2025-08-01
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: Surmasis Pharmaceutical, LLC in Des Moines, IA, a combination drug/device manufacturer, received a Form 483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, including a repeat observation regarding the investigation of unexplained discrepancies. Additionally, the firm failed to segregate non-conforming materials and lacked proper management review and a written quality plan for its combination products.

## Related Documents

- [483 - 2020-03-19](https://www.keypedia.com/records/483/surmasis-pharmaceutical-llc/cefb989e-c11c-47e4-a8d6-fed612bc523b)

## Related Officers

- [Cecilia H. Kieu](https://www.keypedia.com/people/cecilia-h-kieu/3ba5feb0-d49e-4301-ae5c-b84bd604a159)
- [FDA_PERSONNEL](https://www.keypedia.com/people/aranjeet-singh/7359f43e-0e36-4cdd-a77d-3371d8b44b99)
- [Director of Investigations Branch](https://www.keypedia.com/people/katherine-e-jacobitz/9a713b44-95c4-43a2-83bb-8d30062d8345)

Company: https://www.keypedia.com/companies/surmasis-pharmaceutical-llc/6f9dfe3c-c8c3-4740-b9a8-0ecc1bb9b400

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79