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483
•Surmasis Pharmaceutical, LLC•August 1, 2025

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

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Record Details

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.

Company
Surmasis Pharmaceutical, LLC
Inspection Date
August 1, 2025
Product Type
Drugs
Office
Kansas City District Office
People
  • Cecilia H. Kieu
  • Aranjeet Singh (FDA_PERSONNEL)
  • Katherine E. Jacobitz (Director of Investigations Branch)
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ID · a9754776-fa7b-407d-9e77-3850f1791576

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