# FDA 483 - Surmasis Pharmaceutical, LLC - March 19, 2020

Source: https://www.globalkeysolutions.net/records/483/surmasis-pharmaceutical-llc/cefb989e-c11c-47e4-a8d6-fed612bc523b

> FDA 483 for Surmasis Pharmaceutical, LLC on March 19, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Surmasis Pharmaceutical, LLC
- Inspection Date: 2020-03-19
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Sunesis Pharmaceutical in Des Moines, IA, revealed significant deficiencies in the firm's quality control unit and its investigation processes. The company failed to adequately investigate particulate matter in drug products, out-of-specification laboratory results, and numerous environmental monitoring excursions. Additionally, procedures for preventing objectionable microorganisms were found to be inadequate.

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- [483 - 2025-08-01](https://www.globalkeysolutions.net/records/483/surmasis-pharmaceutical-llc/a9754776-fa7b-407d-9e77-3850f1791576)

## Related Officers

- [Michele L. Glendenning](https://www.globalkeysolutions.net/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)
- [Peng Zhou](https://www.globalkeysolutions.net/people/peng-zhou/ce413ab5-8787-4012-bc8f-9ef55f2c3dc1)

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

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669